Pfizer

Patient in clinic for chief complaint of possible side effect of the covid vaccine which she received yesterday. She states that she woke up at 0200 with chest tightness, achyness and headache. She rates the discomfort 7/10 last night and improved now to 5/10. She denies any worsening with any type of exertion and states that she can do simple things like take a shower, walk across the room, down the street or even stairs without any worsening. She denies any SOB or chest pain--just feels tight. Doesn't feel like she can't get a full breath or get the air out of her lungs either. She received her first of two doses of the Pfizer vaccine yesterday (4:23pm) and had no difficulty with the injection itself and then 9.5 hours later woke up from sleep with this chest tightness as well as achyness and headache.  She states that she had the exact same symptoms when she had positive covid test back in August of this year with the addition of fatigue which lasted for 5 days. At that time it was not felt necessary to do any further testing nor treat with steroids according to cardiology. She does have history of LV non-compaction cardiomyopathy and her last visit with cardiology was about 2 years ago and she had a normal EKG and echo only showed "mild LV non compaction at the apex" at that time. He did not need to see her again until she is 18 unless she has problems. She states that she generally does very well and other than this tightness she does not have any other significant symptoms.

Congestion, breathing abnormal, elevated heartrate , 02 lower then usual , tired , exhausted, fatigue, not usual self , fussy , incosebale. Patient is a non verbal child

Went to sit down and passed out; felt dizzy; nausious/nausia; sweaty; sick feeling; as she was ghost white; bad headache.; This is a spontaneous report from a contactable other Health Professional reported for herself. A 16-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318) via intramuscular on left arm on 02Feb2021 03:45 PM, at age of 16 years old at single dose for Covid-19 immunization. Patient was not pregnant at the time of vaccination. Medical history reported as allergies to medications, food, or other products was reported as none known. Prior to vaccination, patient was not diagnosed with COVID-19. Other medications the patient received within 2 weeks of vaccination included multivitamin and melatonin gummies. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via intramuscular at left arm on 12Jan2021 03:45 PM for Covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported morning after vaccine 03Feb2021 08:00 patient was felt dizzy and nausious. Told her mom and her mom ran over as she was ghost white. Went to sit down and passed out. Patient experienced sweaty, nausia, sick feeling and bad headache. Patient went to the emergency room (ER), they gave fluids and blood work. No heart issues noted. Felt better around 3 hours after. Headache was bad and continued on 05Feb2021 (reported today). Also, still feel nausious and had to lay down. All events occurred on 03Feb2021 08:00 AM. Patient was recovering. It was reported the adverse event result in emergency room/department or urgent care. The seriousness criteria were reported as not serious, no results in death, no life threatening, no caused/prolonged hospitalization, no disabling/incapacitating, no congenital anomaly/birth defect. Patient was received treatment for the adverse event included fluids and heart monitoring. The patient underwent lab tests and procedures which included blood work in Feb2021. Since the vaccination, patient had not been tested for COVID-19. Outcome of events bad headache and nauseous was not recovered, for felt dizzy, as she was ghost white, passed out, sweaty, sick feeling was recovering.; Sender's Comments: Based on the information provided and plausible temporal association, a contributory of the suspect drug to the reported events cannot be completely excluded. Case will be reassessed when additional information is available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

10 hours post injection - fatigue 12 hours fever - 100° Held for 48 hours Fatigue, aches, headache for 72 hours Lymph node on injection arm swollen and painful 72 hours later

1. 48 hours after the first vaccine dose, she developed a raised, red, bump ~4-5cm area on her back with irregular borders. It was slightly itchy but not painful. 2. The area on her back worsened over the next 2-3 weeks and developed dark black scabs. 3. 24 hours after the second vaccine dose (which was given on 2/20/21), she developed scattered lesions on her neck, hairline, ear, face ? some with blisters, some with scabbed tops. Again slightly itchy but not painful. She also had a transient headache and chills that resolved on their own that same day.

The child was administered the vaccine at about 11:15 a.m on 2/7/2021. She woke up about 14 hours later with vaccine side effects the family was prepared for, including headache, chills, nausea, vomiting and fatigue. This all resolved within 48 hours. Approximately one week later, the child woke up again in the night with severe chills in the middle of the night. It was a sudden onset following a week of feeling well. She had to sit in a warm/hot shower for an hour to get warm. She described it as "freezing to death." She has never experienced anything like this before.

My daughter became very dizzy, pale, and hot (sweating through her clothing) almost passing out after receiving her first dose . Paramedics were called, vitals taken, and she was taken to an observation area. She started to feel a bit better after about 15 minutes. She was observed by paramedics and a nurse for another 30 mins and we were able to leave and go home. At home she was exhausted the remainder of the night.

Patient mother reported patient began to shake and she was unable to speak or respond. Upon observation patient was pale, awake, and clammy, responding appropriately . Pulse ox placed on patient O2 sats 98-100, pulse 57, BP 87/45. Patient oriented to person, place, and time. Patient reported feeling weak, complains of headache and neck hurting. Patient reported tingling in her left hand and reported her tongue was tingling. . At this time ambulance was called to transport the patient to the ED.

Patient is a 16 y.o. female who received the Pfizer-BioNtech Covid-19 Vaccine, mRNA, BNT162b2 (PF) 30 mcg/0.3 mL IM Susp, Lot ER2613 on 3/19/2021. The patient experienced the following reaction(s) during the immediate of observation: Patient received vaccine at 4:21pm and proceeded to recovery area where she verbalized to her mother that "I don't feel good." 4:23pm Patient had a witnessed syncopal episode and fell to the ground where she was attended to. Patient was treated/managed as follows: 4:25pm VS BP 118/88, HR 57, RR 18, O2 sat 98% on room air. Patient alert and verbal. 4:35pm: VS BP 144/80, HR 85, RR 18, O2 sat 97% on room air. Patient alert and oriented. Denies shortness of breath, difficulty breathing, or pain. Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. 4:37pm Paramedics arrived and care assumed by paramedics at this time. Patient mother present.

Fever, chills, extreme fatigue, lightheadedness and very sore arm, but more importantly chest tightness that became increasingly worse over 48 hours. My daughter dealt with the other symptoms but her asthma became less treatable over the two days since the second shot. I finally administered the nebulizer and inhaled steroid today after all other treatments failed to relieve her symptoms. She is doing better but I will follow up with the pediatrician.

Patient briefly lost consciousness immediately following vaccine administration. Had shaking, chills, flushed and nausea. Pt had not eaten at all today. Administered oral water, snacks. VS within normal limits. Discharged with mother after 40 min of monitoring.

patient started sweating and feeling dizzy after the shot. she sat down for a while and recovered after sometime. Paramedics were called. they examined her vitals and everything was ok

Approximately 15 minutes following vaccination, the patient complained of headache, dizziness, chest pain and throat burning. I asked that she wait an additional 15 minutes so that we could monitor her. Approximately 30 minutes after vaccination, patient appeared to experience syncope or absence seizure (prev. history). we called 911 and paramedics transported her to hospital

Within 30 minutes after the shot, my daughter had a headache and sore arm. Other than that she was fine until midnight on Monday morning when her tremors increased and spread up from her legs to her torso and arms. The tremors persisted all day Monday even through her cranio-sacral therapy at Medical Center. Her therapist tried to calm down the tremors through frequency specific micro current with no success. Her therapist could tell that her whole system was in "overdrive" which was vastly different than her previous session a week ago. The tremors were so bad that my daughter wanted her wheel chair again. I took a video of her tremors after her therapy session. Her therapist told us to contact her DO, Dr. about it. I did. She was able to crash around 10pm on Monday. On Tuesday, when she woke up around 2:30pm, she still had the tremors but they weren't as severe. We had a telehealth appt with her sleep neurologist, Dr. at 3pm and showed her the video but she doesn't recall ever seeing her tremors in the past. When I spoke to Dr., I shared the video and she was going to discuss it with the therapist as they know each other. My daughter's tremors have never been this bad. She had one major tremor episode in her legs only over 2 years ago which we attributed to her meds at the time; but again, not this bad ever.

Experienced extreme onset of symptoms 12 hours after the 2nd dose w/ intense headache, severe leg pain, painful chills, fever and extreme fatigue and arm weakness in both arms, lasting approximately 12 hours and then subsiding for 12 hours for 4 days - extreme symptoms for 12 hours and then subsides - severity of the symptoms remains the same and doesn't lessen w/ each 12 hour episode. The leg pain is severe. Alternating Tylenol and Ibuprofen provides minimal relief and doesn't break the fever.

Pain in injection area, sharp pain in underarm area, shortness of breath, chest pain, rapid heart palpitations, dizziness, tiredness,

On Tuesday late morning, she texted from school - that her heart was racing. shaking, headache, tummy ache. We brought her home from school. These symptoms - especially the severe headache, nausea, dizziness lasted for 3 days. She missed school as she stayed in bed.

Immediate intense headache. Feeling faint. Lay down on floor, semi conscious. Ems staff moved her to sitting position where she completed blacked out. They struggled to hold her, so they lay her on the floor where she had convulsions similar to a seizure. Completely unconscious at this point.

Patient received her vaccination and stated that she was feeling lightheaded. Patient was cool and clammy, sweating and stated she didnt feel good. EMS notified and hooked up to monitors. IV line was started and patient was transported to the hospital. Patients mother and sister were on site.

Severe hives on arms, legs, and torso. Elevated temperature of between 99-100 F. Began at 11:00pm on Apr 5, 2021, about 12 hours after vaccination. Hives severity continues to increase on Apr 6, 2021 as of about 24 hours after vaccination. Has not yet recovered. Monitoring.

Feeling faint, extreme fatigue, vomiting without nausea (no warning)--foul/sour. Kept complaining that she felt like she was crawling in her own skin, all through her arms and her chest, like an itch from the inside. NO HIVES. No difficulty breathing. Kept her home from school and she slept a lot. Only vomited the one time. She was fine by late afternoon and all symptoms seemed to have resolved by then.

Patient presented for her first COVID-19 vaccine. Approximately a minute after vaccine was given, she was noted to be seated upright in the passenger seat of her car, with head bent forward and eyes open. She was unresponsive, stiff posture, and was placed into a reclined position. She then had some posturing with head turned to the left, no eye deviation or nystagmus, no tonic-clonic movement. Radial pulse was thready, bradycardia was noted, with normal respirations. She was noted to become diaphoretic and pale/ashen color noted to the face and arms. She became responsive within a few minutes, however initially was not able to answer questions clearly. She had no loss of bowel or bladder function. EMS assisted with evaluation. Initial blood pressure 78/31, HR 54, SpO2 100%. EMS then transferred her to the stretcher and she was transitioned from her car to the ambulance. She continued to improve spontaneously with BP 94/61 then 103/60 and HR 86 then 74. SpO2 remained stable at 100%. Skin color improved. She had normal responses to questions, no complaints of headache, dizziness, chest tightness, shortness of breath, numbness or tingling. She had some shaking/voluntary movement of the limbs and body noted, but she could control and stop this voluntarily, no myoclonic or tonic-clonic jerking noted. After syncopal event occurred, mom reported that the patient has a history of syncope routinely with blood draws and vaccines in the past, however this episode was slightly more prolonged and seizure-like activity was different. She has had some jerking movement previously with syncope which lasts 20-30 seconds, different from today's response. No known history of seizure disorder.

Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Shakiness-Medium, Systemic: Tachycardia-Mild

Muscle and joint pain - 9:30pm 04/06/2021 - 6pm 04/7/2021 Headache - 9:30pm 04/06/2021 - 10am 04/9/2021 Chills - 3:30am 04/07/2021 - 6:00 am 04/7/2021 Fever - 3:30 am 04/07/2021 - 12pm 04/7/2021 Nausea - 9:30pm 04/06/2021 - 3pm 04/8/2021 Vomiting - one instance 7:30am 04/07/2021

Within a few hours of vaccine she began to have a very sore arm and headache. Around 1:00 A.M. on 04/09/2021 she began having chills and joint pain, but no fever as the headache continues. The event that concerns us was she began to have tingling in her fingertips both hands. This has been going on since 1:00 A.M. Her NP was notified and they said to watch it over the next few days and report to CDC/ FDA. Patient had Covid December 24, 2020. We waited the 90 days to get vaccinated and had clearance from her doctors.

Pt syncopal episode post vaccination likely due to vaso vagal response. Diaphoretic and unresponsive slumped over at chair. Quickly regained consiousness was alert and oriented NAD, Given water allowed to lay down. Feeling much better. Discharged POV in NAD with father. Diaphoretic and unresponsive slumped over at chair Quickly regained consiousness was alert and oriented NAD

Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: 2 minutes post vaccine, pt complained of feeling hot and was unable to see. pt was feeling dizzy and faint. nurse had pt lay down at vaccination site, legs levated. bp 112/63, hr 67, regular and lungs clear and no difficulty breathing. @1449: 116/63, hr 67, 1453: gatorade and water intake, bp 111/69, hr 61. @1459 up in chair, no complaints from pt, sx has resolved. bp 116/72, hr 72. @1504 121/79, hr: 70. pt states feeling well and refused any er tx. pt wants to go home.

By 4:30 started having chest pains and could not take deep breaths, by 7:00 she was running a high fever of 102, body aches and extreme fatigue. She had a fever all day on 8th and experienced severe fatigue. She is still weak, having body aches and a low grade fever on Friday the 9th. Her chest pains stopped on Thursday.

Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Vomiting-Mild, Additional Details: Patient started feeling dizzy within 5 minutes after vaccine administration. Patient vomitted once during observation period. Patient also stated feeling ringing in ears and vision darkening right before throwing up. Patient felt better after throwing up. Patient was observed for total 30 minutes.

Immediately following administration of vaccine, patient was still in chair, became pale, diaphoretic, had pre-syncopal episode. Regained consciousness, did not fall. Placed in WC, transported to OBS area, completely alert and talking with parents and staff. Patient consumed gatorade, feels well. Finished 30 min obs period without incident. Left with parents feeling well.

Pt received her covid vaccine, pt did not wait, was walking around withfather, she felt dizzy and dad reported she fell. we did not see her fall. She was sitting on 20 when dad came toget us. Pt felt dizzy, ringing in ear, had her lay down on floor with feet elevated. BP pressure reading were 128/75 hr 70, 130/72, 75, pt now feeling better and sitting 108/76 64 108/76 64 and 118/76 76. Pt father declined ems. Pt waited until she felt normal, drank bottle of water, no longer dizzy, went home. Father instructed on emergency care. Followed up call with father at 5:08pm. Fahter reported she was tired, sometimes sob and advised to take pt to e.r. for evaluation.

Within 1 minute of receiving vaccine, patient started to shake and appear to loose consciousness for about 30 seconds. She then came to and was disoriented for just a minute then could answer all questions asked of her (name, dob, where are you) She stated she had an intense headache, had trouble hearing but hear a buzzing sound. Mom was in the room as well, we gave her water and sat with her for about 10 minutes and she seemed weak but okay. They remained in the waiting area for another 15 minutes, she was feeling better and mom was comfortable to take her home as Mom is a Doctor.

Patient has a history of dizziness, headaches and Tourette's syndrome. Immediate complaints of headache, nausea, arm tenderness and being dizzy. Patient was laid down, given water and a snack. She was discharged with her parents after 30 min of observation.

Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium, Systemic: Hypotension-Medium

Systemic: Flushed / Sweating-Medium, Systemic: Seizure-Medium, Additional Details: was laid down and legs elavated once calmed down, ems were called and further treated by them

Systemic: Flushed / Sweating-Medium, Systemic: Seizure-Medium, Additional Details: was laid down, epi given by imer, legs elavated once calmed down, ems called and treated, recovered soon after

pt had first immunization , and within seconds pt felt dizzy, and sweaty. was brought to observation room #1. via w/c w/ mother . Pt given crackers and water . vs - 5:09 pm 100/74 79-18- pulse ox 100% 5:14 pm vs 127/76-65-18 pulse ox 100% 5;222PM VS 113/72 -76- 16 PULSE OX 99%. PT FEELING BETTER , VSS , PT REEASED TO MOTHER VIA W/C AND TAKEN TO EXIT .

started vomiting the next day. We weren't concerned because this was expected and she recovered within two days. She improved the next day but became sick again the day after and every day since. We are now at day 19 and she is still nauseated every day. She vomits periodically about every second or third day. She vomited profusely today on day 19. I am reporting this because the symptoms shouldn't last this long.

pt became very fatigued and has bouts of confusion. She has episodes where she doesnt know where she is or who she is with. She has had one episode that she didnt know who she was that lasted a few seconds. Most episodes last a couple of minutes. Her parents took her to Hospital ER i. They did an EKG and electrolytes- lab work. Test were normal. She was released to FU w/ PCP and Neurologist. She is scheduled to see a Neurologist today 4/13/2021 and is scheduled to have an EEG tomorrow on 4/14/2021. She has an appt to see her PCP on 4/14/2021.

Patient stated in evaluation form that she had passed out once before after giving blood for labwork. She and her mother decided to continue with the vaccination as it had never occurred before after getting a vaccine. A few minutes after the vaccine the patient lost consciousness. Mom stated that her face tensed up right before hand. The patient remained in her chair for the duration of the event. She regained consciousness about 30 to 60 seconds later, and within a few minutes she was conscious but still very shaky, pale, and hot. She was able to sip some water and we put a cool, wet paper towel on the back of her neck. The patient and her mother remained seated and under observation for an additional 15 to 20 minutes with no further issues, at which point they left the store. I followed up with the patients mother the next day and she said her daughter was exhausted last night, but this morning she woke up feeling well and went to school like normal.

Patient received vaccine around 4:30pm. After 10 minutes patient reported that she was having a headache, felt like her breathing was a little bit heavy. Patient was brought to exam room with mother present. BP was 150s/100, O2: 99%, HR: 65, RR 20. No distress noted. Patient was slightly anxious, continued to complain about headache. Denied any blurred vision, changes in vision, nausea, vomiting. Around 4:45, patient was asked to lay down for a while to be observed further and to give her time to relax. Patient was given cold wash cloths for forehead. Patient suddenly became more increasing anxious at 4:49, complained of excruciating headache and bilateral arm pain. Oxygen remained at 100%. 911 called at 4:50pm. Paramedics arrived at 4:55pm. Paramedics checked patient's blood sugar: approximately 345. Patient reported last meal around 12:30pm. Patient was crying and continually stating that her head hurt. She was alert throughout the entire process and able to answer questions. Mother elected to have patient sent to ER for further evaluation. Followed up with family on 04/14/2021. Mother reported that patient was held at hospital for 5 hours, was given norco for headache. Diagnosed with panic attack. Mother reports that patient is doing better today.

Approximately 10 minutes after patient was given the vaccine, she reported feeling slight lump in her throat. We brought her into the clinic room and sat her down. Never had trouble swallowing and did not have any swelling. Felt hot and bit sweaty and light headed. Reports has felt similar ways in past when had blood drawn. We laid her down and she immediately started feeling better. Mom and sister were with her. Refused ambulance or transfer to physician. They were all comfortable her leaving on her own, after we have observed her for over 45 minutes from vaccine.

15 min after vaccine administration, pt experienced frontal headache, diffuse subjective weakness of LE, and gait instability. Admitted to medical center for monitoring and workup.

Admitted to hospital on 4/10 with 2 day history of mydriasis, diplopia with blurry vision, dizziness and balance difficulty. Found to have enhancement of 6th and 3rd CNs on MRI. Patient continued to have blurry and double vision during her stay and mild gait instability. She developed mild frontal headache managed with Tylenol. Her exam was remarkable for mydriasis, mild lateral gaze limitation R>L, mild dysmetria, dizziness and unsteady gait without notable ataxia. No papilledema. Her reflexes were 2+ in her BL UE and LEs. Pediatric Neurology and ophthalmology consulted and followed patient. Eye exam remarkable for bilateral cranial nerve 6 palsy but no other element of CN3 palsy and bilateral dilated but unreactive pupils. Patient treated with IVIG 1mg/kg/day x2 days for likely miller fisher syndrome variant of Guillain-Barre.

Pain between the breasts on the ribs. Started out as seconds of slight pain the day after shot until about 9:30pm when the pain became consistent but was a slight pain. I woke up at 2:30am and my chest hurt really badly. It was a constant pain but the amount of pain was back and forth. It hurt more to lay down and if I bent down it was very painful. I stayed up for an hour and a half until the pain went away. When it did I had sweat a lot and was very hot. I then woke up with little discomfort until an hour after I woke up with slight pain. The pain then has gone off and on but not as painful as it was during the night.

Patient presented to the ER following her first COVID immunization. Symptoms started an hour after the vaccine was administered. Stated her heart felt like it was racing, she had increased SOB, headache, was tired, nauseous, and had nasal burning.

sx: dizziness, headache, chills, scratchy throat at 11:45am. started to have rash at 11:55am. BP checked q 15 min since sx started with readings of 120/80, 118/80, 110/83 mmHg. patient drank sprite and was given 2 tablets of diphenhydramine 15 mg by mouth. At 12:11PM rash resolved and sx slowly disappearing. Patient left at 12:22PM with little headache.

No immediate response, approx 4 hours after dose started not feeling well passed out 3 times with 5 minute time frame, EMS called, became coherent while they were route, continue to improve and vitals were checked and advised to monitor. Currently experiencing dizziness when standing from a seated position consistently with no improvement, also fatigued as well. In touch with Primary Care Physician and am monitoring .

Day 0 (4/1/21) had mild arm soreness. On day 1 (4/2/21), she had chills and sweats and body aches. Took Tylenol and improved her symptoms. On day 2 (4/3/21) in the morning she felt well, but later that afternoon she had severe abdominal pain. She had worsening symptoms over the next few hours, with recurrence of sweats, nausea and then vomiting. She had resolution of symptoms after 15 minutes, but recurred about 1-2 hours later with vomiting and abdominal pain. Mom reports her pain was crippling, doubled over and on the floor due to pain. Took to urgent care for evaluation. UA and UPT negative. ED records show abdominal exam was normal except for "increased peristalsis". Treated with Zofran with resolution of vomiting. discharged home. Abdominal pain self-limited and resolved without further intervention within a few hours.

Patient complained of feeling "dizzy and seeing black" at 1200. Patient assisted to zero gravity chair. Vital signs taken at 1200 (Blood Pressure 116/70, heart rate 65, SPO2 99%). Patient appeared diaphoretic. Patient offered water. Vital signs taken at 1210 (Blood pressure 116/74, Heart rate 72, SPO2 99%). Patient stated "I am feeling better." Vital signs taken at 1215 (Blood Pressure 110/64, Heart rate 74). Patient advised to follow up with primary care provider. Patient stated at 1230 that she is "feeling much better." Patient left facility unassisted with a steady gate.

lethary and altered mental status 2.5 weeks after COVID vaccine. Found to be septic (hypotension, hypothermia, suspected infection). Admitted to ICU. Required 15L vapotherm for respiratory support and several fluid boluses for blood pressure. Urine culture resulted positive for a bacterial infection. Started on antibiotics and improved. Concern for vaccine adverse event is low.

pt informed mom that she was not feeling well. nurse in observation lane witness seizure. pt was unconscious for 5-10 seconds. pt vomited as well. bp was 104/54 at 1154a, 107/52 at 11:52a, rest of vitals WNL. Md assessed, observed for additional 30 minutes. pt stated she was feeling well and was driven home by her mom

Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Hypertension-Mild, Systemic: Shakiness-Mild, Additional Details: pt complained of dizziness. lied down w/ feet elevated + used ice packs. stated this has not happened before. BP very high on 1 reading (233/108) and decided to call EMS out of precaution. begain shaking after a few minutes of ice packs but stopped after a few minutes of removal. EMS evaluated, sat pt up, and once pt was sitting up began shaking again and they decided to take to hospital to get checked out.

Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Medium, Systemic: Seizure-Medium, Systemic: Weakness-Medium, Additional Details: Patient fainted in chair shortly after receving vaccine. She came to within a minute, but body became very rigid and she began to seize throughout her whole body. This lasted less than 30 seconds and she was very pale and lightheaded. Patient decsribed feeling extremely nauseous with chills, slowed breathing and lightheadedness. Moved patient to a new area to elevate feet, stated feeling better but was extremely nauseous and unaware that she had fainted or seized. 911 called per parents request

Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Weakness-Mild, Additional Details: Tingling in face and legs

"Administered - 13:50 Adverse event started - 13:55 Patient had flushing/sweating, lightheaded. Patient states did not eat. BP 100/53 (63), HR 60, RR 16, O2 98%. Crackers, water given. Patient stable, released from vaccination site."

The patient passed out completely while sitting after having her 1st covid vaccine. She was alert shortly thereafter but had blurry vision and low blood pressure. She said she was very hot and was sweating somewhat. We gave her some water and gradually she started feeling better. In the meantime, we had call 911 and when they evaluated her, they felt it was somewhat of a panic attack since she did have anxiety before getting the vaccine.

Fever, chills, muscle pain, joint pain, tiredness, headache, injection site pain, injection site redness, nausea

All night so far: Severe headache, body aches, excessive vomiting throughout night, dizziness, almost passing out, confusion, weakness

Pfizer-BiNTech COVID-19 Vaccine EUA: dizziness, that started the morning after the vaccine and still lasts for the 2nd day. Nausea on the morning after the vaccine. Headaches off and on.

Pain and swelling in both feet and ankles, pain started evening of injection, swelling 2 days later. Still tender/swollen 4 days later. Headache/Nausea on day 2.

Time of shot: 3pm Onset of reaction: 9pm Stomach ache and headache Hour later: fever (99.5) and chills Difficulty sleeping Kept her home from school today (4/22/2021)

pt started feeling really dizzy and nauseated immediately after taking the vax. she started having a seizure and made a growling type of noise and urinated on herself. The nurse at the vax site helped bring her back and was told to take her to a doctor. She was monitored and released from the vax clinic when her BP was 107/76. She was taken to medical center where she saw. She was told she had Syncope due to the stress of the situation of getting the vaccination. She is resting today and seems to have some fatigue.

Low fever, chills, vomiting, disoriented, bad headache, adversion to light and sound, weakness, tired

Patient had fever, headache, body aches on 4/20/2021 by 4/21/2021 she had bloody urine, upon arriving in our office on 4/22/2021 she had 3+ blood in her urine analysis.

Pt. received her second Pfizer dose at 3pm. By 11:30pm she had significant swelling on both of her eyes, mouth, and the start of red splotchy skin on arms and legs. We took her to ER. They gave her 50mg of hydroxizine and sent us home. 5min after leaving the ER at 12:30am on 4/23 she felt a golf ball sized lump in her throat and was having difficulty breathing. We brought her back to the ER. At this time they gave her an ekg, and at around 1:30am gave her an epi pin and an oral steroid. Within 5min of the oral steroid and epi pin she no longer had difficulty in breathing and the lump in her throat was gone as was the res splotches. By 5am the swelling in her face had reduced drastically to 90% normal in her left eye and 70% normal in her right eye and 70% normal in her lip. She was released from the ER at 5:45am and went home to sleep. At 11:30am on 4/23 her swelling in her face remains the same and she is complaining of a headache. She was given 50mg more of hydroxizine.

16 y.o. female who received the Pfizer-BioNtech COVID-19 Vaccine, mRNA, BNT162b2 (PF) 30 mcg/0.3 mL IM Susp, Lot EW0158 on 4/23/2021.The patient experienced the following reaction(s) during the immediate of observation: Tinglings, blurry vision, diaphoretic. Patient was treated/managed as follows: Pt brought to treatment area to lay down on mat with legs elevated. VS: 4:15 pm BP: 100/80 R: 18 HR: 58 O2: 98% Pt reports feeling much better after laying down. 4:30 VS: BP: 105/78 HR:60 O2: 99% Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. Pt escorted to car with mom by nurse.

My daughter was given her 2nd COVID shot at approximately 9:00am on 4-16-2021. We waited 30 minutes after the shot. No issues. That evening at approximately 6:00pm, she had a red rash on her upper chest and throat. She stated that she was having a hard time breathing and swallowing. I gave her a Benadryl tablet and watched her for approximately 15-20 minutes. she continued to feel tightness in her throat and said it burned when she swallowed. She confirmed again that she felt her throat was swelling. I drove her to the closest ER located at. My daughter was seen and it was determined that she was having an allergic reaction. DR recommended continue Benadryl tab every 4 hours for the next 12-24- hours. We were discharged to home. I administered another does of Benadryl at approximately 10:15pm. My daughter went to sleep. I woke her up at 3:00am to check on her and she stated she did not have a rash and her throat was fine. She was running a low grade fever of 100.5. I gave her 500 mg of Tylenol for the fever. When my daughter woke later that morning at approximately 8:30am, she still did not have a rash or throat swelling. Her fever was gone.

Patient developed fatigue and headache within 24 hrs of receiving 1st vaccine, over the next several days she developed periorbital edema and cervical LAD. 6 days after vaccine she developed fever and chills and was febrile to 103. She went to the ER and labs revealed pancytopenia. She was admitted on the evening of 4/20 and was observed for 36 hrs. Symptoms improved without antibiotics

I got the shot at around 4 in the afternoon and after sitting in the waiting area for around 15 minutes I was allowed to leave. When I left I only had a slight headache, but nothing that seemed very noticeable. I felt a tad woozy but it was nothing serious so I went on with my day and went to my sports practice for an hour and a half. After I got home and had eaten, I was working and started to feel the effects. It started with an increasingly worse headache at around 9 and as the night went on it got worse and I constantly needed to lie down. My arm had started to feel sore but it was nothing much. I thought I could sleep it off but woke up feeling horrible. My stomach could not hold any food down and my headache had become really bad. I had to go to my sports game but on the car ride over (around 45 min) I got very nauseous. Throughout the course of the day my headache would get worse any time I tried to run and all I wanted to do was lie down and sleep. I was barely able to stand, let alone run and I felt sleepy all day. My arm had also gotten very sore and any contact on it made me flinch back. I was not able to eat or drink anything until about 4 in the afternoon and my stomach was not sitting right the entire time and I constantly was burping and feeling like I was going to vomit despite having only water in my stomach. After I was able to eat the stomach ache went away a bit but the headache lasted through the night and has finally started to subside two days later.

Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild

Intense headache for 2 days 102 degree fever for 2 days light sensitivity for 2 days fatigue, nausea, and body aches for 2 days treatment: 500 mg acetaminophen every 6 hours while headache lasted, cold washcloth on forehead and eyes, lots of sleep and water

Friday : soreness at injection site,3 hours later severe migraines; fatigue Saturday - severe migraines, fatigue Sunday,- -Vomiting, severe migraines, joint aches Monday - awoke with swollen face - centered around eyes and cheeks area, achy headaches, fatigue - went to ER and received Steroid shot.

Pt received her first dose of Pfizer vaccine and at 1148 started to c/o tongue and throat "beginning to swell". Pt states hx of the same with penicillan. Pt is with mother. Pt was given 25mg Benedryl PO at 1200. EMTs called to evaluate Pt and released by medics home with mom. VS per medics at 1215 BP 114/68 HR 70 RR 16 O2 sat 98% RA

First experienced heart racing, fatigue, dizziness and heaviness in your legs followed by hives that moved throughout the body including face, hairline, ears, legs, arms for the next 2.5 days.

Headache about a week, but decreasing during that week, tiredness for about 3-4 days, soreness at injection site about 1-2 days, general itchiness most prominent between 2 - 5 days after, still there but I think that is due to the fact that I scratched it when it was most prominent.

Tightness in chest, extreme nausea, dizziness, headache, shortness of breath. After receiving the vaccine I had these symptoms for the rest of the day, as of this writing I am still feeling mostly nausea and the tightness in my chest has died down.

Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: Patient has been fasting and did not mention to immunizer that she passed out twice today because she is not eating anything only water. Paramedics came and check on her and patient was stable and recovered at the time.

Within 2-minutes of vaccination, the patient experienced a syncopal episode. EMS evaluated the patient on-site. The patient was hypotensive (84/44) with a FSBG of 59mg/dL. EMS administered 15g PO Glucose. IV access was attempted but not obtained. Upon re-evaluation, the patient was hypertensive (147/116) and tachycardic (117bpm). EMS transported the patient to Hospital Emergency Department. In the ED, the patient stated they became dizzy and passed out after vaccination. The patient noted that they did not eat anything all day. The patient was hypotensive (99/56). The patient's labs/tests indicated dehydration and the physician administered 1L IV normal saline. The patient was discharged with dehydration and vasovagal syncope.

From 2 days post vaccine, fever, fatigue, sore throat and headaches, lasting about a week. Persistent symptoms of headaches, dizziness, and blurring of vision still present at 19 day post vaccine.

Got her COVID-19 2nd dose yesterday afternoon, woke up around 0300 hrs this morning with fever, chills, body aches, headache

Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Mild, Additional Details: After patient was vaccinated she went to wait with her mother in the car (vaccinator did not specifiy to wait in the store). Patients mother came to alert us that the patient was not feeling well. I went to the car with the clinic nurse to check in on the patient. She was responsive however was feeling faint/dizzy/nauseas. Vitals were within normal limits however EMT was called by mother. Patient started to feel better and went home. Patient reports feeling fine now.

Severe diarrhea, chills, hot flashes, nausea. Evening of 4/2 and all day 4/3. Mostly okay in the morning of 4/4. Normal diarrhea treatments like plain diet, lots of water, and anti diarrhea meds (loperamide HCl 2mg pills and 3 were taken over the course of 4/3 with no relief). Severe stabbing abdominal pain that came in waves

Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Hypotension-Medium

Fever, chills, dizzy, headache Fever over 101. Symptoms lasted just over 24 hours. Treatment: rest, ibuprofen, cold compress Same symptoms occurred after 1st shot as well.

Per EMT, patient became diaphoretic and pale suddenly approximately 5 minutes after receiving her first dose of the Pfizer Covid-19 vaccine at a drive-through vaccination site. Patient was in car sitting in the observation area when incident occured. After becoming pale and diaphoretic, EMT lowered the seat and someone held the patient and patient became unconscious for approx. a minute. After consciousness regained, patient wanted to sit-up because she "felt naseous". Patient sat up and the RN called to incident. When this RN arrived, patient was consious and leaning over and appeared pale/grey and cyanotic. 911 called. This RN put pulse-ox on patient and told EMT to get O2. Patient's O2 saturations were in the low 80's and HR 46. Patient immediately layed back in seat of car and put feet up on dashboard and given 5L of oxygen. After approx. 5 minutes on 5L of O2 and laying back, patient's color improved and stated she "felt much better". O2 saturations improved to 100 after a couple minutes on oxygen and remained over 98% on RA X 5 minutes. Patient was not taken to the hospital and someone droved patient home with follow-up. Follou-up the next day: patient was febrile and given acetaminophen and was afebrile the rest of the night with no other adverse symptoms.

Patient fainted post-vaccination. Observed patient beginning to lean forward and RN was able to prevent her from falling. Patient's eyes observed to roll upward while patient became unresponsive to stimuli and diaphoretic. No incontinence. EMS called while patient assisted simultaneously to gurney by multiple staff. Upon lying down, patient awoke and become alert and oriented to person, place, time, and situation, though stayed pale and diaphoretic for several minutes. VS @ 12:55: BP 120/80, P 59, SAO2 99%, resp unlabored. VS @ 13:00: BP 138/83, P 62, R 20, SAO2 99% VS @ 13:04: BP 123/73, P 54, SAO2 99% VS @ 13:10: BP 100/69, P 78, SAO2 98% Sitting at edge of bed without symptoms at 13:05, alert and conversing with staff and mother. EMS arrived at 13:07 - their monitor showed NSR, random blood sugar = 93. Ate a snack and drank juice, symptoms completely resolved. Mother declined transport to ED. Discharged home with mother with post-vaccination instructions, will receive 2nd dose while lying down.

her right hand started twitching shaking uncontrollably; her right hand started twitching and shaking uncontrollably; Her temperature also started rising but did not reach above 100*F; This is a spontaneous report from a contactable consumer (Parent). This consumer (patients mother) reported for a 16-year-old female patient (daughter). A 16-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via unspecified route of administration in left arm on 19Apr2021 (at the age of 16-year-old) for SINGLE DOSE for COVID-19 immunization. She received Pfizer vaccine on 19Apr2021 in left arm and within 2 minutes of receiving it left arm, her right hand started twitching and shaking uncontrollably on an unspecified date. The nurse and the fire department were with her and monitored her for 45 minutes until they suggested her to contact her primary care provider and go to the hospital. In those 45 minutes her right arm started twitching with her hand twitching more. It started going up and down with a flopping motion. Her temperature also started rising but did not reach above 100*F on an unspecified date. She was observed by several doctors in the hospital and was given Adavan (Ativan) for her symptoms which did not subside. She was dismissed from the hospital and was given Adavan (Ativan) again in the hopes that her symptoms would subside in the morning. This morning, only her right hand was still twitching. She is right-handed and could not use her right hand at all as she could not hold a pencil at all, which caused her to be absent from school today. She mentioned that her daughter was healthy, athletic, and had no underlying conditions. Her twin sister also had the vaccine yesterday and experienced nothing but nausea last night with some of the listed side effects. She is asking if there has been reports of this. Waiting to hear from hospital she may need to see a neurologist. Outcome of the event reported as recovering. Response: Referenced PI Section 6 and Section 18 LAB-1457-7.0 Revised: 06 April 2021 No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Fainted 48 hours after shot, sweats, slumped over. Luckily I was there to catch her. Complete loss of color. Came on very suddenly. Could have been catastrophic if she was driving.

Patient Received her first dose Pfizer vaccine (LOT#: EW0173 EXP: 8/2021) at 1140 on 4/30/21. Mother of patient alerted EMT. Mother stated that patient wasnt feeling well. Patient stated that she felt weak and nauseous. Patient was moved to anti-gravity chair to make patient more comfortable. Patient then experienced a syncopal episode at 1155 which lasted about 30 seconds. Patient denied SOB. Patient did not hit head. EMT took patients vital signs at 1157. BP: unable to read, pulse: 70, O2: 100%. EMS was activated. EMS arrived on scene at 1205. EMT transported patient to outside area on wheelchair. EMS transported patient into AMR vehicle and put patient on a 12 lead. Paramedics stated that everything was within normal limits. Patients parents were informed on patients health. Patients parents denied care and signed AMA form. Patients parents stated that they would take patient to hospital themselves. Parents and patient were educated on worsening symptoms of syncopal episode. Patient left vaccination site with a steady gait, unassisted with her parents at 1215.

Runny nose; Sore throat; Body ache; This is a spontaneous report from a contactable consumer. This consumer (patients mother) reported that a 16-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, ER8732) at single dose via an unknown route on 12Apr2021 morning for Covid-19 immunization. She had a runny nose and sore throat before she got the vaccine on 12Apr2021 morning and was figured it was allergy but then the reporter was wondering if she was actually had Covid before she got the vaccine. Concomitant drug was not provided. Patient was very well might just feel badly because of the vaccine. She had a runny nose, sore throat and body ache. The reporter realized she just had a vaccine in the past 24 hours so patient not gotten a test. Outcome of the events was unknown. Reporter seriousness was unspecified. No follow-up attempts are needed: information about lot/batch number cannot be obtained.

16 y/o female with NO PMH and no h/o similar prior experiences/syncope c/o "feeling tired" ~3 min after receiving the 1st dose of pfizer vaccine. Pt LOC, "gently" falling onto the floor, landing on her face ~5 min after receiving the vaccine. Pt reported feeling tired before LOC, not associated with any other symptoms (dizziness, changes in vision/hearing). LOC lasted ~10 seconds, pt immediately returned to baseline. She was sat up with the help of her mother and nurse and the clinical lead was notified. Pt was laid down on a cot, VS were taken, ice was applied to her pressure points. Pt reported complete resolution of symptoms within ~5 min. Pt was progressively moved from lying down to sitting to standing. Pt denies eating or drinking anything today and was given fluids and snacks. Pt was monitored for a total duration of 45 min. Pt was driven home by parents. Pt was advised to eat and hydrate today and for the next dose. Pt and parents were advised to call PCP / 911 if symptoms return/persist/worsen or if pt develops concussive symptoms. Pt was instructed to inform the nurse that she fainted ater 1st dose and to prophylactically lay down prior to receiving prior to second dose vaccination.

Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Tingling at site of injection. Patient was seated after receiving the vaccine and suddenly collasped. Patient maintained consciousness throughout the episode and her symptoms have improved.

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe

My daughter developed a rash to her inner arms, inner legs, and hands. Warm to touch. Raised rough textured rash. The skin that is affected is swollen. Benadryl taken orally did not help decrease the rash, nor did topical Benadryl. She also complains of pain to her left leg from her hip to her knee that intermittently bothers her starting 4/30 and still continues to bother her. The day after the vaccine was given she had injection site pain, tiredness, extreme headache, fever of 101.8, nausea, chills, body aches. No swelling or redness to injection site. No lymph node swelling.

FIRST VACCINE WAS ON 04/11/21 NO SIDE EFFECTS. SECOND VACCINE WAS ON 05/02/2021 AND HAD THE FOLLOWING SIDE EFFECTS: HEADACHE, STOMACH ACHE, HOT FLASHES, NAUSEA, FATIGUE, FEVER 101

0935- Vaccine recipient (VR) received 0.3ml dose of Pfizer vaccine that was reconstituted with the incorrect amount of diluent (0.9mL). VR was asymptomatic during 30 minute observation. Immediately contacted program and was provided guidance and information. 1052 - Consulted School Nurse, VR was in nurses office with chief complaint of a headache, dizziness, and nausea. Left deltoid observed at injection site with no localized reaction found. Per school nurse: Nurse gave VR ibuprofen. Relayed information provided by program to VR. School nurse continued to observe. 1058- Contacted and spoke with VR's parent and relayed and emailed information provided from program (continued in next section) Additional information for Item 18: cont'd- which was the CDC Guidance for vaccine administration errors and deviations. Parent advised to contact primary care provider with any questions or concerns. 12:30 - Followed up with VR - headache and dizziness unchanged, nausea resolved, c/o "going the other way" bathroom. School nurses continued to observe. VR laying flat on bed, dim lights, and on phone.

Patient reported feeling lightheaded status post first dose Pfizer COVID vaccine (Lot: EW0167, expiration date: 08/31/2021) to medic. Medic noted that the client was CAOx4, her skin was pale, warm and slightly moist, pupils were equal, round, reactive to light and accommodating (PEARRL), respiration rate (RR) was 20. The client's sister stated the client had a history of anxiety and that "she gets this way whenever she gets a shot". Medic walked patient to the zero gravity chair. The client was given water to sip on. At 1213 baseline vitals were taken with client sitting: Blood pressure (BP): 110/82, heartrate (HR): 98, RR: 20, PEARRL. Medic reports she coached the client on her breathing to help alleviate her complaint of feeling lightheaded, mild nausea and anxiety. Client reported she felt anxious prior to her vaccination and that her last oral intake was 15 minutes prior to vaccine. Client denied headache, blurry vision and chest pain. At 1220 a second set of vitals were taken while standing: BP 108/80, HR 86, RR 16, CAOx4. Client stated her symptoms were diminishing. Client's RR slowed down to normal rate and rhythm, vital signs were trending to normal and client was negative for orthostatic pressures. Client was advised to stay for additional 30 minute observation. Client's symptoms resolved completely and she was able to ambulate away from observation site without assistance and with a steady gait.

Pt complained of nausea and feeling dizzy immediately after vaccination. Patient became diaphoretic, pallor to face, patient assisted to wheelchair and taken to stretcher and laid flat since unable to stand. BP 108/67, HR 57, RR 14, o2 sat 99%. Patient later reported she left better, color returned to face and diaphoresis ceased. Updated vitals: BP 109/71, HR 52, RR 16, o2 sat 100%.

In the morning I woke up with fatigue and it was difficult to get up. I also had body aches throughout the day. I had a bit of nausea and was dry heaving. Later in the day I had a headache

16 yo female came into our injection site today 05/05/21 to receive her first pfizer vaccine. She was accompanied by her father. Pt received vaccine IM to her left deltoid. Pt completed vaccine at 2:55pm at which she sat down for her 15 minute observation period. As soon as she sat down she called over the staff that administered the vaccine. She explained to her that she felt nausea and was breathing heavily. I then walked over to them and the attendee was very pale and breathing heavily. By that time I had RN getting attendees history from her father, She has no history of allergic reactions, not taking any medications and no current illness. She is "slightly asthmatic" but is not taking any rx. RN was helping me by putting cold pack behind attendees neck. Pt then proceeded to explain that she felt nauseas and starting dry heaving. RN then brought over trash can and attendee started to vomit. I then started to proceed and take her vitals. first set of vitals were taken at 2:58pm BP: 90/60 HR: 132 RR: 24 O2: 100%. Attendee at this point was diaphoretic, pale, breathing heavily and vomiting. We continued to monitor attendee in which she started to feel better by 3:08 pm. She was no longer pale, diaphoretic or vomitting and was breathing normally. We provided attendee with water and continued to monitor her. Now that pt was calm, I was able to ask her some questions. She stated that she had a smoothie and an avocado toast about an hour prior to vaccine. She explained to me that she does have a phobia to needles and was feeling very anxious prior to appointment. I then repeated her vitals at 3:16pm BP: 98/60 HR:89 RR: 20 O2: 99%. I had attendee stand up off chair and walk at 3:22pm. She felt fine and did not feel dizzy at all. No signs of distress noted. She was then discharged and walked out with her dad at 3:25pm.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Tachycardia-Mild, Additional Details: pt released to her father. spoke with father a few hours later. pt is fine.

Pt was asked to stay for 30min observation. Approximately 10-15mins post vaccination, client developed hives and began coughing which progressively got worse. Fire/EMS on-site and attended to client. Client was observed for an additional 45mins and given Benadryl. No relief from benedryl and pt transported to ER via squad where she was observed and released. 5/6/21-per mother, the clients pediatrician was notified and advised that the client not receive the second dose of vaccine unless in a controlled environment. Pediatrician. Additionally, client had continued with cough while in school which required a visit to the nurse and use of inhaler times 2.

At approximately 9 AM on the morning after receiving the second dose, the patient became dizzy at school. As she was walking to the teacher's desk, she lost consciousness and fainted, hitting her head on a desk, scraping her neck on a desk, and suffering several other minor injuries from the fall. She was immediately seen by school nurse and released to my care for the rest of the day. She rested at home and then was seen in at Walk-In Clinic to be evaluated for a concussion. On Day 2 after receiving the vaccine, the patient reported a sore throat, but no other symptoms. She was seen on the third day post-vaccine by our pediatrician's office for possible strep. She tested negative for strep and a concussion from her fainting episode was confirmed due to the lingering headache.

At approximately 1:04pm on 04/30/2021 patient during 10 minute observation had a syncopal episode and fall from standing to floor with loss of consciousness. Trauma assessment found contusion to occipital region of skull. No bleeding, no other trauma findings. Pt moved to wheelchair, and then to cot without incident. Pt AA&Ox4, airway patent, breathing shallow and non-labored. Pulse strong and regular with delayed perfusion. Pt skin pale, cool and dry. Pt eyes PERRL bilaterally. Pt complains of pain 7/10, dull, localized, to the base of skull, and ringing of ears, as well as dizziness without nausea. Pt administered 650ml oral water with improvement to skin and respirations. Vitals and report continued on next page Pt however post oral hydration still stated no change to headache, and new onset tinnitus to left ear. Pt parent was consulted for transport to emergency department for assessment for potential injury post fall, and consented. EMS was contacted, who transported patient to hospital. Vital signs as follows 1312 108/68 93p 14r 98%RA 1323 106/62 82p 17r 98%RA 1335 104/60 74p 16r 97%RA

it seems like patient have vasovagal symptoms 5 minutes right after vaccinated. she was nauseated and sweat and almost faint. she said that she has hard time breathing. WE gave her 0.3mg epinephrine then she is ok and better. we called EMS over. and she is all fine after that. SHE did not need to go to hospital.

Accompany minor with dad received vaccine for first time. Pt complain of dizziness, diaphoretic, pale to face, body stiffness and started jerking once on floor. Pt placed to floor for safety precautions. V/s obtained w/ b/p 80/54, HR 92 O2 98%. Jerking stopped with v/s obtained again w/ b/p 82/56 HR 95 O2 99%. EMS arrived and taken over care. Pt was more a/ox3. Taken to hospital via EMS.

Patient was seen at the urgent care clinic on 4/19/2021 having congestion for a couple of days as well as cough, news throat the head and troubles breathing was noted to have normal oxygen saturation and was given an albuterol inhaler and told that she had a virus. She followed up in the PCP office on 4/21/2021 with worsening troubles breathing and was given Decadron in the office, 4days of prednisone, CXR and labwork. CXR showed possible reactive airway disease and was to do steroid and continue out albuterol every 4 hours. Had negative/normal lab work and positive Covid antibodies. History of Covid 10/2020. Felt almost completely back to normal by Sunday, her last day of steroids. On Monday had worsening of her breathing throughout the day, increased troubles breathing again after softball that night. Albuterol did seem to help up. Called the office as she woke up Tuesday morning with worsening and would started on Flovent. With no improvement return to PCP office on 4/29/2020 with marked inspiratory stridor. Was admitted to the hospital for work-up of return of stridor. Had a normal chest x-ray and neck/soft tissue x-ray. With continued troubles breathing and chest pains with decreased heart rate was elected to go to Hospital where she could have further work-up. When the ARNP came helicopter, was concerned about her airway and she intubated to fly to hospital. Was dx there with Sudden Acute Onset of Vocal Cord Dysfunction and is continuing with therapies.

Approximately after 1 minute from receiving her first pfizer vaccine the patient reported to her mother that she feels like she is going to pass out. This RN was alerted about the situation by the patients mother and when approaching the patient this RN noticed the patient losing consciousness and drawing her arms to chest and curling her hands with tremors throughout her body. This RN placed the patient on the floor for safety out of the chair and had other staff member contact 911. Tremors lasted approximately 30 seconds and patient regained consciousness however appeared tired and stated she is unware of what just happened. Vitals were taken which were within normal limits and continued to be taken frequently until EMS arrive to transport patient to Hospital

Developed headache, chills, hot flashes, body aches, burning eyes, nausea, and fatigue 4 hrs after vaccination. Symptoms wax and wane in severity, but have not resolved. She was seen by pediatrics and family practice by telemedicine. Treated with Tylenol and Advil. Then presented to Hospital ER 5/3/21 with worsening fatigue and weakness. ER work-up included normal/ negative CBC, d-dimer, monospot, CMP, ESR, CK, UPT, UA, RP Covid, and Influenza. Only noteworthy finding was mildly elevated CRP at 0.51. Treated with Zofran. Outpatient follow-up work-up included normal ECG, normal repeat CBC, CMP, CK, ESR, A1C. CRP 3. EBV, CMV, Parvovirus, Covid antibody, ANA, and RF pending. She briefly D/C'd Amitriptyline, so advised to resume.

Nausea and fevers started at 4:30 am 14 hours after shot, had nausea, body aches, headache, fever up to 101.2 , dizziness, fatigue. Nausea lasted 72 hours after the shot and has not stopped though has gotten better.

16yoF was accompanied with an adult who was present for the vaccination. The COVID-19 Vaccine Pfizer-BioNTech 0.3mL administered IM in right deltoid while patient was sitting. Patient remained sitting for 10 minutes after administered dose. Patient reported feeling well after the injection. Patient stood up while we continued to talk, after 2 more minutes passed out while standing. Suddenly, patient begain to go limp and her eyes crossed and rolled back. Patient fell backwards into the privacy curtain and into aisle 13 of the store. Patient's head bounced off the floor. Immunizer knelt next to patient. Patient was unresponsive until immunizer placed cold hand on back of neck and front of chest to check if she was breathing, immunizer calmly guided patient to breath, slow deep breaths into the belly and patient's eyes fluttered open. She said her head hurt really bad. Immunizer offered to the accompanying adult to call EMS because patient should be evaluated after hitting her head so hard. The accompanying adult denyed EMS, then stating that patient had previously fainted while walking and said that she would be fine. Immunizer advised patient to remain laying down while immunizer got some ice. Ice was then placed on the back of the head. Patient slowly stood up after laying for 10 minutes and was walked over to a sitting area to put feet up and continue with ice for another 5 minutes before the accomanying adult wanted to leave.

Numbness in tongue, right sided facial droop, difficulty closing right eye, headache, jaw pain. dx with Bell's Palsy

Pt became dizzy and diaphoretic approximately 5 minutes after vaccination. She sat down and began to feel better. She reports fear of needles and not eating since 12pm that day. Approximately 10 minutes later she lost consciousness for approximately 30 seconds. Pt came to was given orange juice and left with her father around 20 minutes after vaccination.

Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Systemic: Seizure-Mild, Additional Details: Parents were with patient. says it happens every time she gets shots or blood work. possible NES and/or hypotension. says its happened in docs office before and they're testing her for pots and her sister has non epileptic seizures. She was fine after about 15 minutes. gave her a cold packet to put on the back of her neck and just monitored her for further symptoms.

20 hours after receiving the vaccine I felt very dizzy and nauseous for a moment and then fainted and was unconscious for a minute. I had developed a fever about 8 hours after receiving the vaccine, but by the time I fainted the fever was pretty much gone.

Felt dizzy and nauseous at about 7:30pm following a workout 3 hours after I got the Pfizer vaccine. Dizziness has increased and I feel fatigued.

Patient complained of feeling dizzy and blurred vision, headache and eyes hurting. Denies any c/o nausea. BP 114/64 HR= 99 O2 Sat= 99% Patient/mom verbalized that she had a half of subway sandwich prior to her vaccination. Placed patient in supine position, took vital signs and instructed to remove her jacket since the observation area was warm. Gave her cold drinks, bar of candy and Tylenol 500 mg 1 tablet for headache. Continued to monitor patient then 30 minutes later RN walked her on the hallway. Still a little wobbly . Instructed to take some deep breaths. Mom did mention that her menstrual period is almost due. 10 minutes later she claims she is doing better but still have mild headache and sleepy. Discharged home with her mom and was instructed RN will follow up on her. Instructed if headache persists and start having dizziness to go to ER.

The complaint is characterized as a skin rash. The onset of the symptoms have been rapid and they have been occurring for 3 days. The course has been decreasing (pain had improved by visit on 5/10). The skin complaint is described as moderate to severe. The location is described as on the right side of trunk. There has been associated itching. She has a history of chronic back pain: aches. She said this is occurring as well as the new and worse sharp pain. It was worst last night. She was achy Wednesday morning into Thursday after vaccine. She felt a little better Friday morning, Friday evening she became tired and her back was hurting again. The rash and itching started on Saturday morning, Sunday was worse. There was burning, sharp pains on her side with the rash. Diagnosis of Shingles (B02.9). Started Acyclovir 5%. Apply 3 times daily for 7 days. Follow up in office if symptoms don't subside or get worse.

Severe headache for a week after the vaccine; This is a spontaneous report from a contactable consumer. A 16-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on Apr2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not received any other vaccine prior to COVID vaccine. The patient experienced severe headache for a week after the vaccine on Apr2021 which resulted in doctor's clinic visit. Prescription migraine medication was received as treatment for the event. Patient was not diagnosed with COVID prior to vaccination and had not been tested post-vaccination. Outcome of the event was not recovered.

Patient felt dizzy. Became pale and diaphoretic. 1215 - 98/52 HR 54, repeat at 1220 110/64 HR 78, repeat. 12/25 patient feels better, able to ambulate, alert and oriented. 1234 symptoms completely resolved and able to resume normal activity.

One day after the vaccine, feeling fatigued, feverish (99.5), headache Two days after the vaccine, feeling some SOB w exertion, chest heaviness Mild chest heaviness 3 days after, resolved by end of day.

pts arm hurt immediately after taking the vax. Later that night her legs were feeling very heavy, her arm still hurts, joint pain in both hands, slight fever, has body aches and pains. On 5/12/21 they contacted her PCP and was told to give them a call back if her symptoms get worse.

The patient felt tired and describes her eyes going dark, then passed out a few minutes after vaccination. She was vaccinated and then left the immunization room to sit down for a 15 minute waiting period. When she went to sit down, she collapsed on the floor. Her mother assisted her into a chair. She continued to be incoherent and have her eyes rolling back into her head for a few minutes. We used a cool cloth on her forehead and the back of her neck. The parents requested that we call 911. EMS arrived shortly and evaluated her. Heart rate, blood pressure, pulse ox, blood sugar and chest sounds were all within normal range. The patient stated that her arm felt heavy and "funny". She then stated that her tongue felt funny. EMS evaluated her tongue and said it looked normal. To err on the side of caution, she was taken to the hospital to determine whether or not she was having a delayed onset anaphylactic reaction. This patient has no history of seizures.

Patient chronic conditions (JIA, UC) previously controlled on adalimumab. Within several days of receiving COVID-19 vaccine dose #2, patient began experiencing worsening/flare of ulcerative colitis symptoms including stomach pain, diarrhea, fatigue, arthritis pain that lasted beyond the reasonable and known duration of vaccine related side-effects. Symptoms treated with dicyclomine and acetaminophen with no relief. Symptoms continued x 2 weeks. Patient ultimately required addition of budesonide to treatment regimen for ulcerative colitis and is currently having relief of symptoms.

pt was shaking and not feeling well at 3:10pm (10 minutes after vaccine was administered at 3:00pm). pt was given 2 oranges because pt describes having episodes of low blood sugar. Clinical staff spoke to mother and informed about event.

Sore arm with rash/swelling at injection site, lasted a week. Fever and chills that evening through the night. Extreme fatigue, slept for 18 hours. Abnormal menstruation (spotting for 8 days prior to actual period, started 2 days after vaccine)

12 hours post vaccine she had severe myalgia, rash on both arms and legs, headache, nausea, stomach pain, and mild swelling in legs. Over the next 48 hours the rash darkened and spread to the entire body causing pain in her skin. The myalgia became nearly unbearable and both Ibuprofen and Acetaminophen didn't put a dent in the pain. One side of her face swelled so that one eye could only partially open. The nausea and stomach pain worsened so that she couldn't eat. Headache became intense. By 48 hours post vaccine she became delirious - her speech was slurred and difficult to comprehend. She would fall asleep for a few minutes and wake up unaware of where she was or what was happening. She never got a fever but did have chills. Around this time I called a relative who is a doctor to seek advice and Diphenhydramine was recommended. Benedryl helped immensely. 30 minutes after taking it she could speak clearly, was more alert, pain became tolerable, and her appetite returned. Symptoms and swelling returned when the Benedryl wore off so she continued taking it every 4 hours for the next two days until it wasn't necessary any more. The myalgia, stomach pain and headache persisted for 7 days. At 8 days post vaccine (today) a mild headache, mild and intermittent stomach pain, and mild fatigue are her only remaining symptoms. Her pediatrician cannot see her until next week but we have an appt for the 22nd.

Pt developed chest pains and heart racing that night along with high fever 102 with very bad headache. Chills and fever and weakness latest through Friday afternoon Fever started to go down Friday afternoon and weakness improved. Headache remains strong

Within 5-10 mins post-injection pt became pallor, sweaty, dizzy and had a vasovagal episode while sitting in her chair. Pt exhibited jerking motions and then quickly had a syncope episode lasting <1 min. Pt was lowered to the ground during the episode. No trauma occurred. Pt mother beside pt entire time. During this time a pulse ox was put on pt and her legs were elevated. Pulse ox remained 96-98%. After waking, water and wet rag was given to pt and pt moved to reclined chair after 5 mins. Pt remained pallor and dizzy x15mins, after 40 mins pt was able to walk and leave the clinic. Mother stated in past that pt had a vasovagal episode after the Gardasil vaccine.

Right after patient received the vaccine she turned very pale and told the technician she felt light headed. She remained seated in the room and closed her eyes a couple times but never appeared to lose consciousness. Her dad joined us in the room and confirmed she was really nervous before the vaccine. We kept her seated for several minutes and then she said she felt sick and vomited. After that she started to regain her color and was able to move to the waiting room. She sat there for about 5 more minutes and then felt well enough to leave with her dad.

16-year-old medically complex female, JIA, bronchiectasis and chronic nighttime oxygen requirement who presented to the hospital on 5/6 with fever, increased stool output, and perianal skin breakdown. Her course was complicated by respiratory failure (requiring ICU admission for CPAP), pancytopenia, diarrhea with buttock skin breakdown requiring rectal tube for wound and stool management, and extensive workup which was unrevealing for an infectious cause. She clinically improved with respect to pancytopenia with discontinuation of felbamate, and completed a treatment course with Zosyn for suspected buttock SSTI.

Thrombocytopenia noted; Elevated temps to 104; Associated chills; headaches; This is a spontaneous report from a contactable healthcare professional. A 16-year-old non-pregnant female patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 1 intramuscular on 25Apr2021 (Lot Number: EWO171) as 1st dose, single for covid-19 immunization. Medical history included eczema, Pyle disease, food allergies, short stature, seasonal allergies, peanuts allergies and nuts allergies. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. The patient did not have other vaccine in four weeks. On 26Apr2021, the patient had elevated temperatures to 104 [unspecified unit], 4-5 days post vaccination (pending clarification) with associated chills and headaches. Thrombocytopenia noted. The adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment was provided for the adverse events. The patient was tested post vaccination with a nasal swab test on 28Apr2021 and the result of negative. The reporter did not consider the events was serious. The outcome of the event was recovering. No follow-up attempts are needed. No further information is expected.; Sender's Comments: The reported event thrombocytopenia was observed only 1 day after vaccination. It is unlikely that thrombocytopenia is related to BNT162B2. It's more likely intercurrent medical condition. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Extreme abdominal pain/cramping. We ended up taking her to the ER department at the Hospital because the pain was so extreme. In the course of the visit to the ER, they took a CT scan of the abdomen, and there saw evidence of Covid in the lungs. They did a nose swab test, and she tested positive. She had some mild symptoms (stuffy head, headache, mild sore throat) earlier in the week (May 8 - May 9), but we thought it was possibly allergies. Turns out it was Covid and we didn't know it. It seems that with the Covid virus already in the system, the shot caused an extreme reaction.

Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: Parademics/911 called, patient's parent refused transport to the hopsital. Patient waiting in recovery with NP and nurses, RPH to check

Immediately after the shot she had a bad headache and approximately 30 to 35 minutes later dizness, chills, and throat restriction (anaphlaxis), extreme muscle soarness( any sort of touch was extremely painful, and she couldn't move her neck, it hurt to move from side to side. Her legs began to feel extremely heavy and hard to move. These symptoms seemed to last for approx 30 minutes. Headache didn't subside until later in the day, it did lighten up.

Patient presented to the ED with dizziness, fever and heavy vaginal bleeding around 24 hours after receiving her first dose of the Pfizer-BioNTech COVID-19 vaccine. She was tested for active COVID-29 infection via nasal swab PCR and tested positive. Upon presentation labs were drawn and her platelet count was found to be 8 on 5/15. Repeat labs were drawn that day to confirm low platelet count and confirmed diagnosis and thrombocytopenia secondary to an immune reaction to the vaccine was suspected. She was admitted and was started on tranexamic acid, medroxyprogesterone, dexamethasone and IV immunoglobulin (Ig) to help treat low platelet count and vaginal bleeding. As of writing, she is still admitted and her most recent platelet count on 5/17 was 16.

Client received 1st COVID vaccine Pfizer (Lot#EW0185 expiration 05/22/21). At 4:28PM Client reports headache, no dizziness, no lightheaded, no blurred vision, no chest pain, no shortness of breath. Client has already completed 20 minutes of observation. EMT obtained vital signs blood pressure 116/71, heart rate 87, oxygen saturation 98%. At 4:33PM, RN responded to the event. Client and father reports history of asthma and no known allergies. Offered supplemental nutrition and fluids. Client accepted. Client reports to RN about no chest pain, lightheaded was improving, headache is going down. At 4:39PM vital signs are blood pressure 130/84, heart rate 96, oxygen saturation 99%. Client reports lightheaded, blurred vision, no shortness of breath. RN educated Client and father in regards to ED precautions and common adverse effects of COVID vaccine. 4:44PM vital signs are blood pressure 121/79, heart rate 92, oxygen saturation 98%. Client reports no chest pain, no shortness of breath, lightheaded is improving, headache is going down, no blurred vision, no dizziness. Client remains sitting in a chair and eating/drinking supplemental nutrition and fluids. At 4:49PM vital signs blood pressure 118/78, heart rate 89, oxygen saturation 99%. Client reports all symptoms has resolved. Client has a steady gate and is waiting for other siblings to complete observation.

Patient received vaccine in her left arm. It was made aware to the immunizing technician prior to vaccinating that the patient had a history of dizziness after vaccines. Patient was seated when receiving shot and after stayed seat. About 30 seconds after the shot patient lost consciousness and fell out of the seat hitting her head on the way down. The pharmacist and mother helped patient back to her seat. As she came to consciousness patient reports a little headache and dizziness. Pharmacist took blood pressure which read 84/52, temp 97.9 and gave patient some water and 911 was called. As EMS arrived patient reported still some dizziness but was feeling better.

At approximately 1:04pm on 04/30/2021 patient during 10 minute observation had a syncopal episode and fall from standing to floor with loss of consciousness. Trauma assessment found contusion to occipital region of skull. No bleeding, no other trauma findings. Pt moved to wheelchair, and then to cot without incident. Pt AA&Ox4, airway patent, breathing shallow and non-labored. Pulse strong and regular with delayed perfusion. Pt skin pale, cool and dry. Pt eyes PERRL bilaterally. Pt complains of pain 7/10, dull, localized, to the base of skull, and ringing of ears, as well as dizziness without nausea. Pt administered 650ml oral water with improvement to skin and respirations. Vitals and report continued on next page

Briefly, patient is an otherwise healthy 16-year-old female who presents with 12 days of epigastric pain in the setting of getting her 2nd COVID vaccine on 5/5. Did have fever and vomiting during the first 24 hours which has since subsided, but the abdominal pain has persisted. She has had a reassuring work up through her PCP but presents with continued pain. Labs overall reassuring with normal LFTs and lipase. Awaiting RUQ US and urine at this time. 0100: Family requesting discharge home. does not want to wait for US as they have an outpatient US scheduled for Thursday 5/20. Temperature: 36.6 DegC (05/18/21 01:14:00) Systolic Blood Pressure: 118 mmHg (05/18/21 01:14:00) Diastolic Blood Pressure: 60 mmHg (05/18/21 01:14:00) Heart Rate: 80 bpm (05/18/21 01:14:00) Respiratory Rate: 20 br/min (05/18/21 01:14:00) Oxygen Saturation (SPO2): 98 % (05/17/21 20:28:00) On re-evaluation, patient is awake, alert and well-appearing. She has remained afebrile, with normal vital signs for age. Reports improvement in symptoms, has tolerated PO and feel that she is appropriate for discharge home. Anticipated course of illness reviewed. Supportive care (rest, push fluids) discussed. Reasons to return to the emergency department discussed in detail. Written instructions provided. All questions answered. Parents expressed understanding and agreement with this plan. Patient was awake, alert and well-appearing upon discharge home from the emergency department. Final Diagnosis 1. Epigastric pain R10.13 2. Adverse reaction to vaccine constituent T50.A92A

vomiting began 3 days after vaccination fever up to 102 began 4 days after vaccination sore throat, congestion, body aches persist 5 days after

10 minutes after receiving vaccination, attendee had complaints of feeling "dizzy and fuzzy" and intermittently staring off into space. Parent,(mother), present at bedside and states staring off into space occasionally is a baseline behavior for attendee but 'seemed worse' at this time. Vital signs at 4:10pm: blood pressure 130/90, heart rate 124, temp 99F, respirations 22. Blood glucose 93. EMT present. At 4:20pm attendee assisted to lie down on cot. Paramedics called as attendee felt she should go to hospital. Attendee transferred to gurney at approximately 4:30pm and was looking at her phone and requesting her headphones and drink of water. Pt seemed more attentive and appeared in no acute distress. She was able to stand and move her legs to transfer to gurney. Attendee transferred to hospital via fire station vehicle at 4:40pm.

A few moments after receiving the vaccination, patient fainted and had some tremors afterwards. We picked her up off of the floor and placed her in a chair. She was pale and had some discoloration around her nose area. She was able to speak to us. She felt cold and was sweating at the same time. Her body temp was 97 degrees F. According to her mom, she's had a previous reaction similar to this but not to this extreme with the HPV shot. We called 911 to have her assessed by the paramedics

Patient felt lightheaded and dizzy after 2nd dose of Pfzier, was pale and diaphoretic but alert and oriented x4. Had pt lay done supine and observed for an extra 15 minutes. Pt felt fine and symptoms resolved. Left with father feeling better

Swollen Lymph Nodes, 16 hours after injection, Rest, Fluids, Benedryl 10 mg - Symptom persists Itchy Throat, 8 hours after injection, Rest, Fluids, Benedryl 10 mg - Symptom persists Low-Grade Fever, 30 hours after injection, One dose of Tylenol - Symptom persists Malaise, 8 hours after injection, Rest and Fluids - Symptom persists

PT HAD A SEIZURE APPROX. 30 MINS AFTER RECEIVING THE COVID VACCINE, PT FAINTED, STIFFENED UP, AND BEGAIN TO CONVULSE. PT WAS PLACED ON COTT IN THE RECOVERY POSITION, 911 WAS CALLED AND VS OBTAINED. P74, R22, BP118/80, O2SAT 98% ON RA. SEIZURE LASTED APPROX 10 SECONDS, AMBULANCE ARRIVED WITHIN 10 MINS, AND TOOK OVER PT'S CARE. PT'S COLOR REMAINED PINK THROUGHOUT, AND SHE WAS SLEEPY BUT ABLE TO ANSWER QUESTIONS APPROPRIATELY. VS: P83, R24,BP116/80, POX99% ON RA. PT TAKEN IN AMBULANCE TO HOSPITAL FOR FURTHER EVALUATION

Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Chills-Mild

Within 15 minutes, pt complaining of chest pain, not radiating, in center of chest. Coughing, stating sore throat. Given PO 50 mg Benadryl. Vital signs stable. No other s/s. Took private vehicle to hospital with RN.

Patient received first dose of Pfizer vaccine (lot EW0170) on 4/24/21 at University and received 2nd dose of Pfizer vaccine (lot EW0182) on 5/15/21 also at University. Came to hospital ED on 5/16 AM with diagnosis of acute chest pain, acute dehydration, and adverse reaction to vaccine administration. Was discharged to home and returned to ED on 5/17/21 for continued chest pain (central, throbbing, non-radiating chest pain). Medical tests and laboratory results revealed elevated troponin level (1.546 at peak, then declined to 0.585 prior to discharge home). Patient was admitted to PICU for close monitoring. CT angiogram of chest was negative, chest x-ray was negative, EKG showed normal sinus rhythm, echocardiogram was done and it was a normal study. Dr. discussed with the cardiology department at Hospital. Possible myocarditis due to vaccine. COVID-10 IgG IgM antibodies were positive for the patient which indicates good efficacy of the vaccine. Patient to have follow-up with outpatient pediatric cardiology Dr. Discussion with father on 5/20/21 indicates that patient's symptoms were improving.

Patient started experiencing numbness and tingling on her right side and then all over on Sunday evening 5/2/21. It affected her gait and the numbness and tingling in her legs caused her to have to catch herself and hold on to something to keep from falling. She described that her legs felt weak for a few seconds when walking. This sensation gradually decreased in intensity and duration. When I saw her at 5 pm on 5/3, she had normal gait and only felt the numbness and tingling very briefly. Her exam including her neuro exam was normal on 5/3 when I saw her. The sensation of numbness and tingling completely resolved by 5/4. She also experienced HA, nausea and fatigue, but did not have syncope, dizziness or fevers.

arrhythmia, heart palpitations, pain in left arm, pain in chest (particularly left side) radiating into shoulder blade, fatigue, muscle aches

The patient had a Vasovagal response. She had a 15 second seizure ,blood pressure dropped, was flush, tired and nauseated. She has no memory of the event.

pt began to fill light headed about 5 minutes after vaccination. She then had some vomiting. The room was very warm. She was a little diaphoretic. The vomiting happened about 3 times then subsided. Patients color came back. She sat for a few additional minutes. Drank some water and left clinic completely stable. She has had a history of fainting with heat and with injections.

nausea within 1/2 hour. congested and runny nose within 1 hour. within 24 hours sore throat, cough, vomiting. Still has runny nose and cough.

Nausea; headache; soreness at injection point; fever; runny nose; This is a spontaneous report from a contactable Consumer (patient). A 16-year-old female non-pregnant patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EN5318, Expiration date not reported), via an unspecified route of administration in arm left on 27Jan2021 (at the age 16-year-old), as a single dose for COVID-19 immunization. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included escitalopram oxalate (LEXAPRO). The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL3249, Expiration date not reported), via an unspecified route of administration in arm right on 06Jan2021, as a single dose for COVID-19 immunization. The patient did not receive any other vaccine in four weeks before vaccination. The patient experienced nausea, headache, soreness at injection point, fever and runny nose on 27Jan2021. The patient did not receive any treatment for the events. The outcome of the events was reported as recovering Follow-up attempts are completed. No further information is expected.

Developed severe headache 15 min after returning to class following vaccination . Approximately 30-40 min post vaccination FAther came to school and will transport his daughter to an Urgent care center for evaluation

Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Nausea-Severe

6 days following vaccination, patient was exercising for the first time. started feeling dizzy. She had some water and realized that her skin was red. She had a rash on face and puffy lips. Mom came to get her she stood up and was extremely dizzy. Mom did not notice that her lips were swollen but did notice that her skin was rashy and red. Mom, who is a nurse, also thought she appeared pale and diaphoretic. By the time they got the ED she was hypotensive. She got a cocktail of meds in the ED including a couple doses of EPI. She got IV fluids. She started to improve quickly after giving the medications.

Covid vaccine administered on 5/20. 1704 - in observation room pt complained of feeling warm and a sore throat. 1706 - 50 mg Benadryl PO given, VS HR 93, POX 99, BP 128/68 1710 - VS HR 97, POX 98 1712 - pt states throat feels better. 1715 - pt states throat feels okay. 1720 - pt states she feels fine. No dizziness, throat all better. 1723 - VS HR 97, POX 99 1725 - VS HR 93, POX 98 Pt monitored by 2 RNs for 30 minutes throughout this encounter prior to leaving observation.

Dizziness, headache, sore throat, tiredness Large painful lump near collarbone on left side notice the morning after when she woke up, still present.

I am her mother reporting and also an RN. She rarely complains of symptoms whenever I?ll. C/O 12 hours post vaccination began feeling of throat closing- able to breath ok/safely but short of breath (O2 says 99% HR 60?s - WNL), feeling floaty and light- as if not on ground, body feels tingling and numb, difficulty sleeping, right pupil dilated greater than left but both pupils reacted to light appropriately with check. Pupil over dilation one side resolved by next morning. Other symptoms still continue. Other SE?s are common: HA, low grade fever 100.9, body aches. Currently 33.5 hours post vaccination at submission. Pfizer #1 on 4/30/21 Lot# EW0173 Pfizer #2 of 5/21/21. Lot# EW0187

Fever, body aches, headache, tingly limbs. Symptoms started around 4am, so about 17 hours later. Symptoms were gone by 48 hours later.

Patient received the vaccine at 4:00p. Her mother called us over at 4:05 as Shaelynn was feeling "weird". She began to itch and cough, apparently trying to throw up, felt her throat was itching and swollen. She stated she couldn't swallow and was having a hard time breathing (although she was breathing). We administered an Epi Pen 0.3mg (only one) and called 911. Patient was transported to the hospital by ambulance.

1. Headache - for 24 hours. Treated with acetaminophen & naproxen. 2. Nausea when standing - duration 24 hrs 3. Dizziness when standing - duration 24 hrs 4. Fever up to 103 F - duration 18-24 hrs. Unknown due to taking acetaminophen & naproxen.

Vasovagal response immediately after vaccination. Dizzy, pale, lightheaded, diaphoretic, hypotensive. B.P. 64/25 @10:25 and @10:35 B.P. 110/60. Laid down in medical screening with good rebound Blood pressure. Remains for 30 minutes observation. Left in stable condition at 10:53.

Pfizer-BioNTech COVID-19 Vaccine EUA I woke up at about 4:30 AM and couldn?t fall back asleep, I kept feeling sleepy until I would get jolted back awake over and over. My joints were hurting, I had somewhat severe nausea, my head started throbbing. At about 6:40 AM my migraine started, my arm felt hot to the touch, and I got dizzy so I took some acetaminophen. At 10:00 PM I noticed the area under my left armpit was a little swollen and really sore, my throat and right tonsil was also sore and it hurt to swallow. The next day (today) I have another migraine, my throat and left armpit are still sore, and my muscles hurt. I?m getting better though.

Vaccine administered at outside facility. Patient is a 16 yo girl, admitted on 4/19 with myocarditis, s/p IVIG (4/19) after presenting with progressive new onset chest pain. She was in usual state of health up until 2 days ago when she started developing body aches, and chest pain. Patient received her 2nd Pfizer COVID vaccine last week (4/15). No known history of COVID infection. Parents brought her to the ED yesterday after she complained of dizziness, SOB, chest pain, and had a near syncopal event. EKG showed non-specific ST abnormalities with labs showing elevated troponin, mildly elevated CRP, normal CXR, negative COVID PCR. Denies fever, GI symptoms, GU symptoms, headache, rash. Once transferred to our PICU, she was worked up for myocarditis vs MIS-C. Troponin has been trended q6 and is trending up (now 11). Of note, there have been no fevers. Patient is a 16 yo girl, s/p admission (4/19-4/23/21) with myocarditis, s/p IVIG (4/19), has now been readmitted on 5/10 with myocarditis after presenting with headache and neck pain for 2 days. Following discharge from the PICU on 4/23, patient states that symptoms have lingered (low grade fevers, feeling tired, on and off chest pain). After developing a progressive headache and neck pain, she came back to the ER for re-evaluation. Upon readmission, her troponin was elevated (2.06 on 5/10). Her CBC and CMP were reassuring. Blood culture collected on 5/11 and urine culture collected on 5/10. ID consulted for workup.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Seizure-Medium, Systemic: Shakiness-Medium, Additional Details: Patient had seizure with 1st vaccine, pediatritian informed mother to have patient lay down if it happens again. Patient said she felt out of it (at 11am) after administration of this vaccine so we helped her lay down on the floor with her head proped up. Gave her water and turned on the fan to try and make her more comfortable. Patient decidede to try sitting up slowly after 10-15 minutes, then after another 10 minutes she was able to stand and felt back to normal and left the store 11:30am.

hives developed in the evening after first vaccination, treated with otc oral benadryl. Hives of scalp, neck, face and shoulders developed after the second vaccination on 5/19/2021, which was partially treated with otc oral benadryl. The day following the 2nd vaccination, the patient developed nausea with vomiting, fever, sweats, shaking and chills for one day.

16yo female pt had syncope episode approx 15 min after vaccination. Parents said they had just come off of a long international flight and that pt was very tired and had not had anything to eat or drink. After vaccination, the family walked around the store, and pt fainted on other side of store. Emergency services were called. Pt was helped to sitting upright in a chair, and had a scraped knee.

Started with a headache that over time worsened. Seen at PCP office on 5-4-2021 and then again on 5-5-2021. Sent to ER for further care.

Felt dizzy and like she would pass out Felt faint and nauseous and very sweaty. MOM noted she was obviously sweating and left wet marks from her arms on the table Did have a syncope episode

With in 5 minutes patient began having throat itching, tongue tingling, and lips swelling. Face broke out in hives and patient was shivering.

This patient received the Pfizer vaccine on 5/24/21 at 4:30pm and was feeling fine until the next morning at 5:30am when she felt dizzy and passed out. She then was able to get back up and passed out again. Her guardian states that she was gray in color and was very weak. She was able to communicate but was very tired and stayed at home for 2 days. Today she is feeling fine and guardian was asking if she should get the 2nd dose. I said that she should contact her physician.

5 days after vaccination- loss of smell and taste, shortness of breath, sneezing, coughing, ear infections, fatigue, and headache.

Sharp, stabbing unilateral headaches lasting 1-3 seconds, initially 2/day, now 15/day. Different from baseline headache type. Started day after second dose.

FEEL QUEASY; AWFUL HEADACHE; This is a spontaneous report from a non-contactable consumer, the patient. A 16-year-old non-pregnant female patient received 1st dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number/Batch Number: UNKNOWN), solution for injection via an unspecified route of administration in the left arm on 14March2021 at 10.30 am as a single dose for COVID-19 immunisation. The patient was allergic to gluten (celiac), Zithromax and Augmentin. The patient concomitant medications include Zoloft (Manufacturer unknown) , Junel birth control (Manufacturer unknown) and Claritin (Manufacturer unknown). On 14March2021, the patient experienced awful headache and queasy. The patient has recovering from the event headache and queasy at the time of reporting. Information about lot/batch number cannot be obtained. No further information is expected.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Severe, Systemic: Vomiting-Mild, Additional Details: Patient temp at time of incident was 96.8. About 8 mintues after vaccination was given patient became pale and passed out for several seconds. Patient was dizzy and vomited. No other symptoms. Called paramedics to make sure patient was okay. Gave patient some water and spoke to patient until the paramedics arrived. Paramedics took her vitals and after while they cleared her. She was able to walk out on her own and went home with her father and brother.

Pt has history of anorexia. When she arrived at 1:00pm stated she had only eaten 1/2 banana today. Stated she has lightheaded and dizziness frequently and right then. RN instructed her to go and eat something before her vaccine could be given. She returned at 2:15 after eating a whole roast beef sandwich. Vaccine was given and she immediately began feeling even more lightheaded than her norm, per her. She was assisted to lay flat on the floor and feet placed up on the chair. She stated that helped but still was feeling poorly. 911 was called. She was diaphretic and got a severe headache, stating she was blacking out and unable to see. She never lost consciousness. Mother remained at side. EMT took her to hospital.

103 degree fever, migraine, severe joint pain, GI got significantly worse (pain in stomach); went to ER; admitted overnight to hospital since they could not get the fever and migraine resolved; spent two days in the hospital treated with various medications including Tylenol and magnesium

The afternoon of May 4th, (the patient) had a headache at the back of her head. She took an Ibuprofen and went to bed. Over the course of the next 3 weeks, the headache would return, but was alieved with Ibuprofen. On the evening of May 23rd, 2021 (the patient) came to me and said she had a twitching in her neck. I looked, but did not see anything that was concerning. It was just a twitch. On the evening of May 24th, (the patient) went to dinner with her father. On the way to dinner, they were having a regular conversation when (the patient) began to stutter really bad. Her father pulled the car over and looked at her. He noticed her head was shaking uncontrollably and she could not talk. He immediately took her to the emergency room. When I arrived, it looked like she was having a seizure. (The patient) has never had any kind of speech problem, so she has never stuttered. the drs told us that they did not have a neurology dept, so we took her to another hospital. After numerous tests, we were told to take her home and it was probably something like stress and she should see mental health

Patient had fever and nausea with some vomiting roughly 5-10 minutes after receiving vaccine. Patient also had some trouble breathing but it resolved within a five minutes. Gave patient cold compress over her neck and monitored her breathing and nausea. All symptoms resolved and she was able to leave facility.

Shortly after receiving vaccine (about 5 minutes), pt complained about difficulty breathing. I went to check on her and she appeared pale and seemed very drowsy and unresponsive to questions. She continued to complain about dizziness and nausea. Her parents grabbed some water for her and still there was no improvement. I called 911 to report the symptoms and was advised to administer EpiPen. When asked if her breathing improved, she nodded yes, but she did not appear to have improved. She continued to be unresponsive to questions and appeared extremely drowsy. Within 15 minutes, the ambulance arrived.

The patient was previously well then shortly after the first COVID vaccine she began experiencing fatigue slowing to her swim times ( she is an high level swimmer) and felt "Off". She presented to my office on May 6, 2021 three days after her second COVID vaccine I examined her and heard a slight hint of a wheeze and in addition to labs did a CXR which was Abnormal with evidence of a LLL consolidation and a pleural effusion. We then did a CT scan with contrast and started her on antibiotics and I called Pulmonology to get her in quickly since swimming trials were approaching and we had to do our best to get her in shape to compete. We also did a rapid COVID test which was negative at my office on May 7, 2021-- The pediatric pulmonologist repeated the CXR 5 days later and there was more fluid and she was now having more sx of cough and feeling worse so she was Admitted to the Hospital on May 11th and had a Chest tube placed and drained 950 cc of serous fluid . Pulmonology, oncology and rheumatology consulted to rule out various other causes of the pleural fluid in an otherwise healthy girl. Surgery did the procedure and followed up outpt. She was in the hospital for approximately 4 days. Proximity of sx onset to doses and other sources being essentially ruled out lead to concern for vaccine complication.

Myocarditis. Chest pain started 2 days after the 2nd shot. Elevated troponin and went upto 20. Near syncope and tiredness.

Approximately five minutes after injection, patient began feeling faint, nauseated and weak. Her parents had her sit down. She began vomiting and sweating. We called 911. Her Dad starting taking vital signs. He is an ER Dr at local hospital.

Shortly after receiving vaccination client became pale and diaphoretic, c/o blurry vision and fell from chair. She received a minor injury to her right knee which was treated on the scene by EMS. BP 91/50, 02 99%, HR 46

Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium

Patient received the Pfizer vaccine. Patient left to sit in out waiting room after vaccine. Patient's mother informed in a few minutes that the patient was not feeling well. She stated that the patient felt hot. I grabbed an ice pack on my way out to her. I put the ice pack behind her neck. Patient passed out within a minute of me getting to the patient. She came back to quickly and stated that she was having a hard time seeing and hearing. She then again passes out. At this point I made the decision to call 911. I delegated to my tech to call 911. She called 911. I asked my other tech to come help me thinking the patient my have needed to be lower to the ground. The patient again regained consciousness. At this point I asked tech to call our Store Director and inform them. I also asked that she get me a water for the patient. The patient was feeling better and drank some water. She then again passes out. This time we were struggling to get her to regain consciousness. I used sternal rubs to help the patient regain consciousness. I was having a hard time finding her pulse. This lasted for a minute or two and then she stared responding. Right then EMS arrived and took over. I gave them the information I had and they took her vitals. EMS decided that she was stable and could go home to be monitored by mom. I did call the Mother the next morning to check on the patient. The patient did well last night and was feeling good this morning.

Fever 37.5C, fatigue, headache, swollen lymph nodes, back of the neck pain, stomach ache, pale complexion. Missed school, stayed in bed at home until symptoms resolved.

Patient: Felt tired 5 minutes post vaccine administration. Treatment: no medication was given. patient was under observation. Water improved symptoms Outcome: symptoms resolved and patient was sent to POV/Home.

delerium; Severe myalgia; full body rash; swollen legs; facial swelling; slurred speech; stomach pain and cramping; nausea; headache; injection for vaccine received same date; injection for vaccine received same date; injection for vaccine received same date; This is a spontaneous report from a contactable consumer (patient). A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in left arm on 15Apr2021 (Lot Number: EP7533, at the age of 16-year-old) as single dose, and second dose via an unspecified route of administration, administered in right arm on 15Apr2021 (Lot Number: EW0171, at the age of 16-year-old) as single dose for covid-19 immunization. Medical history included post streptococcal reactive arthritis and bee sting allergy. The patient's concomitant medications were not reported. On 16Apr2021, the patient experienced severe myalgia, full body rash, swollen legs, facial swelling, slurred speech, delerium, stomach pain and cramping, nausea, headache. Headache and stomach pain have lasted 7 days. Rash and myalgia lasted 5 days. Delerium, facial swelling, leg swelling and slurred speech lasted 12-24 hours and were relieved by Benedryl. The treatment for the event included Ibuprofen, Acetaminophen, diphenhydramine. The injection for vaccine received same date on 15Apr2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not pregnant. The outcome of the events severe myalgia and full body rash was recovered on 21Apr2021, for events stomach pain and cramping and headache was recovered on 23Apr2021, for other events delirium, swollen legs, facial swelling, slurred speech, nausea was recovering.

Patient reports immediately after receiving the vaccine she developed chest tightness and pain that has continued to wax and wane the past two weeks. Has some intermittent difficulty breathing and fast heart rate that each last about 20- 30 minutes. Also accompanied by dizziness or lightheadedness. Reports her whole right leg feels tingly and her joints hurt, but denies weakness, redness or swelling of the joints or right foot. Also has a continuous headache that started within an hour of receiving the vaccine and worsened over the next few days. This too has waxed and waned.

I woke up not feeling well. I was pale in color and felt nauseous, light headed and my ears were ringing. I took my blood pressure and the reading was 120/71 with a pulse of 54 which is really low. I went to the Dr. to be evaluated. Dr. felt it was a vasovagal response. I will continue to monitor myself and if it continues, I will see a cardiologist.

1st dose: fatigue, slight headache, pain in left arm. during arm circles, would be pain during movement pain for a day or two. Took Tylenol 2 tablets 500mg each on the night of the vaccine. 2nd dose: received vaccine at 5pm, during night of vaccine day, got a fever and headache and chills. flu-like symptoms for 24 hours. fever of 101F. soreness of muscles. on second day, fever was almost gone. lasted 2 days total. most severe symptoms on first day. Took Tylenol 2 tablets 500mg in the morning, 2 tablets 500mg in the evening. Took 1 tablet of Advil 200mg on day 2.

My daughter had a mild seizure 5 minutes or less after receiving her first vaccine. She fell out of her chair, her eyes fluttered and rolled in the back of her head, her teeth were clocking and chattering and her body was shaking mildly. She lost consciousness for approximately 2 minutes. At 8:33 pm she felt a second seizure begin, her step father grabbed her before she could fall and again, her eyes fluttered and rolled in back of her head, her teeth were clicking and chattering and her whole body was shaking. The second episode lasted approximately 2 minutes as well, with her losing consciousness again. She was taken to the emergency room and stayed overnight for observation.

Syncope x 3 in the early morning hours (around 3am) about 14-15 hours after vaccine. She had had headaches that is intermittent, throbbing, phonophobia but no photophobia, from back of head to top of head and behind eyes, taking Advil or Excedrin intermittently with relief for a week prior to covid19 vaccine. Syncope, longest lapse was two minutes, her sister found her. She went to Medical Center ER at 0400, was assessed and scanned, neg CT scan of head, and was discharged home. Has felt some fatigue today due to not sleeping early the night before, has returned to school since concussion, with normal learning, and denies any exertional physical activity due to pre-existing torn ACL, torn medial meniscus L knee. After evaluation by ER, was given IV fluids, determined cause to be dehydration.

At 15:05 voiced complaints of feeling tired and dizzy. Crying and scared. Her mother was in attendance. They gave her some orange juice. No tachypnea or dyspnea. Skin warm and dry. 15:10 – Attendee stated that she "felt funny". Attendee assisted to the cot and given orange juice. 15:13 - HR: 78 BP: 120/80 O2Sat%: 99. 15:16 –Water given 15:20 -No voiced complaints- skin warm and dry. Attempted to sit her up and she reported dizziness, so she laid back down. HR: 75 BP: 110/70 O2Sat%: 100 Temperature 98.7 15:25 – Sat up on cot the and dangled her legs without dizziness 15:26 – Assisted to a chair and denies feeling funny or dizzy. 15:30 - discharged to home with her parents

Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: blurry vision-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: Patient reported leg weakness and blurred vision and dizziness/slight difficulty breathing upon getting ready to leave observation area. Said she hadn't eaten in a while and felt cold due to A/C in the store as well. BP was low and HR high, so called 911 to get her emergency help as she didn't feel like she could walk out of store safely. Felt strange and that her legs might give way. EMS arrived, vitals looked good, pt refused ambulance.

At about 3pm on 05-01-2021, my daughter started acting crazy. She does have a history of leukemia which was treated 07-03-2020. She has history of neurological problems from chemotherapy. She also has down syndrome. She has headaches since the vaccine. She is non speaking, non-verbal. After her Pfizer vaccine, my daughter repeat things over and over, at night she cries, moves her hands a lot, yells when she is at school. My daughter did not have a fever, body aches after her vaccine. I feed her, bathe her and take care of her and since receiving the Pfizer vaccine she is not the same person. Before the vaccine, my daughter was sociable, respected, educated but since the vaccine she has been out of control and acting crazy. My daughter received the Pfizer vaccine at a clinic and the doctors there said that she should not get the second dose. At this time, my daughter is scheduled for an MRI appointment on 06-18-2021.

She was having a sore throat. I took her to the primary care doctor for it. They put her on antibiotics. She just got done with the medicine yesterday.

At the time of the vaccine daughter dizzy and started to fade out 20 minutes after the vaccine. She couldn?t see and it seemed like it was a Vaso Vagal response which resolved quickly. At 5am the woke up with a fever of 102 and extreme left arm pain. The fever was controlled with Tylenol. Two days after the vaccine she woke up complaining of chest pain and a knot under her left arm. It felt like something was pressing on her chest. We went to the ER and all tests were negative. The feeling lasted until the end of the day. Three days after the shot the next morning she got a headache for half of the day and resolved with Tylenol. The next day all symptoms were gone. Emergency Room Dr.

5/28 - swelling of right eyelid, 5/30 - swelling of left eyelid, burning eye pain, itchy, felt dizzy, trouble focusing, fatigue

Bleeding & bruising happened instantly as the injection was given. Within 2 minutes (walking to the waiting area) she was feeling dizzy. By the time we sat down she said she felt like she was going to be sick. She began sweating - it was dripping off her head and neck and her eyes kept closing. She was extremely pale and her lips were white. She was like this for approximately 10 minutes.

approximately 5 minutes after vaccine, patient experienced paleness, nausea, tingling throughout body, stomach tightness and sweaty

Pt w/ hx of allergy to penicillins (rash) & HPV vaccine (unknown reaction). Pt had syncope, flushing/sweating and dizziness. BP 119/76, HR 78, RR 18 -- > 107/61, 72, 18. Recommended to the patient to take 2nd dose supine. Pt stable and released from the vaccination site.

Patient's mom reported that patient had chest pressure and felt tired on Saturday 6/5/2021 (pt got 2nd pfizer covid 19 vaccine dose on 6/4/2021) per mom. Pt's mom was advised to contact PCP or visit urgent care or ER if symptoms get worse. Called pt's mom next day to follow up on pt's adverse reactions. Pt felt better and chest pressure went away per pt's mom.

My daughter experienced fatigue, GI issues, heart racing, anxiety, jittery (these are signs that her thyroid is not working). All her thyroid issues were off, her TSH value was up to 6. My daughter still has her symptoms of anxiety, GI issues and anxiety.

3:40pm pt. c/o lightheadedness, ringing in ears and getting sweaty. Patient requested water. Water was provided. BP 117/66, HR 66, O2Sat 99% on RA.

Fever and chills on the 8th and 9th; Over the last couple of weeks, several times that I've gone to doctor. On May 18th, she had what was considered to be a pre-syncope event (almost passed out). And she had a pretty large migraine headache as well - the headache lasted for days - for probably three days. 18th, went to dr and they took her vitals. They were under the impression she passed out from having the migraine (her blood pressure is low but normal, in general). Dr was called on Monday 24th - doctor wanted tests. She had another pre-syncope event on May 1st in school and then had a fever the rest of the week. (From 6/1/2021 - 6/6/2021 - fever and threw up and bad headache - fever until yesterday). I did take her pediatrician. Negative for COVID and Strep on 2nd . She had another migraine on Tuesday. Pediatrician said it could be a viral infection of some sort. Neurologist believes the migraines were exacerbated by the viral infection as well. This one has lingered and it's the first time she had a migraine within a week or two weeks of each other. She was out of school was out 2 1/2 days last week and the week of the 18th she was out of school the 19th and got sick again the 20th and was out.

Pt was laying down for 2nd Covid vaccination as she fainted for 1st Covid vaccination. After 2nd vaccination was given- she had a vaso vagal reaction. BP 102/72 Pt has had 4 episodes of ears ringing & pressure both sides of head. Recommended to see her primary Dr. after leaving clinic.

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Severe, Systemic: Hypertension-Medium, Systemic: Shakiness-Severe, Systemic: Tachycardia-Medium, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Severe, Additional Details: Patient appeared weak, pale, sweaty, shaky about 5 minutes after the first dose was given to her. She complained of visual disturbances and progressive shortness of breath. Stated her throat felt a little tight but was not experiencing and swelling of of any parts of her face. She then complained of an intense headache that was getting worse. Patient was admitted to the hospital to make sure she was ok.

Patient admitted with myocarditis s/p dose #2 of the Pfizer COVID-19 vaccine. At the time of the report, she is still hospitalized. From EHR note: Patient was in her usual state of health when she received her second dose of the Pfizer mRNA Covid vaccine on 6/3. She experienced mild myalgias in the day following the vaccine. However, on 6/5 she developed new severe substernal chest pain, dizziness, and dyspnea. Pain radiated to her throat. Given severity of pain, she presented to the emergency department. In the ED she was afebrile, tachycardic, and initially hypertensive. Labs demonstrated WBC 10.9 (N 49, L 27), Hb 11.7, PLT 315. ESR 25, CRP 7.61. Troponin T was mildly elevated at 0.08, consistent with mild cardiac inflammation. SARS-CoV-2 PCR and antibody testing were negative. An EKG was normal. However, an echo demonstrated low-normal LVEF (55%). Otherwise, patient denies nausea, vomiting, diarrhea, cough, runny nose, conjunctivitis, new rashes, arthralgias. Patient was admitted to the cardiology service for further monitoring. Following admission, she was started on ibuprofen. She notes that her substernal chest pain has improved somewhat since admission. Differential for patient's presentation includes infectious, post-infectious, and non-infectious causes of myocarditis. Although post-vaccination mild myocarditis seems likely, we agree with the infectious workup already undertaken, and recommend additional EBV and CMV PCR testing.

sepsis; myocarditis; pneumonia; This is a spontaneous report from a contactable HCP (nurse). A 16 years old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular in arm right on 01May2021 10:00 AM (Lot Number: EW0175) at single dose for COVID-19 immunization. The patient is not pregnancy at time of vaccination. The patient's medical history was not reported. The patient had no known allergies (NKA). The patient's concomitant medication was reported as no prescribed medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Symptomatic COVID-19 (Non-PCR rapid NAA) from nasal swab on 19Dec2020 was negative. The patient admitted on 19May2021 with sepsis secondary to myocarditis and pneumonia, status post (s/p) intravenous immunoglobulin (IVIG), after presenting with fever, myalgia, sore throat, hypotension, elevated troponin, elevated C-reactive protein (CRP), and leukocytosis with left shift. Sore throat has been present for about a week (onset estimated on 12May2021) and fevers began on 17May2021 with a T max of 103. On 18May2021, she began developing shortness of breath and upon evaluation by the primary care physician (PCP) on 19May2021, she was admitted. During initial workup on 19May2021 upon admission, hospitalist was high concerned as she developed hypotension of 91/48 on 20May2021 at 08:35 am. Computerized tomography (CT) of chest on 20May2021 showed patchy consolidation of the posterior lower lobes bilaterally. Upon transfer to another place, further serologies were collected which showed leukocytosis with left shift, highly elevated C-reactive protein (CRP), elevated troponin, elevated Interleukin-6 (IL-6), elevated ferritin, negative covid antibodies (abs) test, negative respiratory viral panel (RVP), and negative COVID PCR. Coronavirus NAA from nasal swab on 18May2021 was negative. Respiratory Viral Panel from nasal swab on 19May2021 was negative. COVID-19 (Standard NAA) from nasal swab on 19May2021 was negative. SARS CoV2 Antibodies from blood test on 20May2021 was negative. SARS COV2 IgM Antibodies from blood test on 20May2021 was positive. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and hospitalization. Intravenous immunoglobulin (IVIG) 2grams/kg started on 20May2021 at 22:57. The outcome of events was not recovered.; Sender's Comments: Based on the current available information and the consistency with the known safety profile of the suspect product BNT162B2, there is a reasonable possibility that events sepsis, myocarditis, pneumonia were related to suspect drug based on the temporal relation between the vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Fever, urticarial rash to face, neck trunk, and extremities, arthralgias and swelling to hands, feet, ankles, left knee and left elbow occurring 4 weeks after vaccine lasting for 4 days in hospital after 2 days at home. still resolving slowly

Patient felt dizzy, lightheaded, had chills, and a headache about 5-10 minutes after receiving her vaccine. Her feet were elevated, blood pressure taken (87/76), temperature taken(95F) at 5:15pm. She was given a cold compress. Since she hadn't eaten for several hours, she was given some orange juice. After approximately 10 minutes, her blood pressure was taken again and it had elevated (98/76). The patient said she felt better and was able to get up and move around without any other symptoms. She left with her mother at 5:38pm.

After the second dose a high fever onset overnight and lasting throughout next day. Temp of 102.2 with chills, headache, general malaise and exhaustion that slowly resolved over the course of hours until following morning. Overall 24 hours of symptoms.

She experienced severe chest pains within the first 24 hours of the vaccine. The pains have lingered on and off for a week after. She has severe fatigue, headaches, nausea, and bilateral arm pain in both arms like pain in her bones. They are giving her Zofran for the nausea which also causes headaches.

After given Covid19 vaccine Pfizer 2nd dose to patient on 6/8/21, patient feels dizziness, headache and start to faint. We called 911 and paramedic came very quickly. Patient was conscious and we continue monitored patient for about 30 more minutes and she was ok at the store. Advice her dad to continue monitor patient when at home and report if any side effects. We called patient to follow up in the evening and patient is doing fine.

Patient had a headache this morning. At 11:30am she felt hot, so we took her temperature which was 100.0. She then walked into another room and had a febrile seizure lasting 30 seconds. Her face was pale white, her eyes were open and staring off, she moaned initially and then her jaw was stuck open with her tongue making a clicking sound. She urinated herself and then the seizure ended.

Approximately 12 hours post vaccine, she started experiencing intense muscle spasms/twitching and chills. This lasted approximately 3 hours. She stated she was unable to control her hands to work her phone to text or call for help. She stated she could not talk. After approximately 3 hours, she stated she got very flushed and then regained muscle control. She fell asleep amd felt fine when she awoke.

Mom stated that patient reported she did not feel well about 6:30 pm (the same evening). She then sat down, eyes rolled back in her head, speech was slurred and finally, became unresponsive for about 10 seconds. She was sweating uncontrollably, had a temperature of 99.1 F. afterwards. After she came to, she reported that she couldn't hear, eyesight became blurry just prior to incident. Mom stated that she was a little confused. Had some bottled water and felt better. Mom states that today (6/10), she is feeling better. She did not take any medications at that time. (The vaccine clinic was held as a drive-through, with people remaining in their cars). The weather was very warm. Unknown what activities patient was engaging in the rest of the day.

Patient came to college on 4/24/21 after she received her Pfizer COVID vaccine from hospital. She reported chest tightness and itchy throat. Her pulse ox was 98. Her lungs were clear. She accompanied her mother who was coming to college for her COVID vaccine. EMS spoke with patient as did Dr. Pt refused to go with EMS to the ED. She claimed if she had any problems she would go back to hospital.

Patient slept for about 16 hours a day; Severe fatigue; Vomiting; Nausea; Fever; This is a spontaneous report from a contactable consumer (patient's mother). A 16-year-old female patient (daughter) received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 15May2021, as a single dose for COVID-19 immunization. The patient's medical history included ongoing asthma (gotten better in the past year or so but had it almost her whole life investigation assessment: No) and cold. Concomitant medications were not reported. The patient's mother reported that on 16May2021, the patient (daughter) developed nausea and vomiting for about 12 hours and treated with dramamine and went away, completely resolved. She also had fever of up to 102 Fahrenheit for about 3 days that went away and also presents severe fatigue that lasted from 9 to 10 days that started on 18May2021 and was only improving now and wanted to know if that would that be an allergic reaction, when she presented fatigue the patient slept for about 16 hours a day. The hours that she was awake she was normal, she was nor weak. Caller wants to know what can they expect "fatigue wise" with the second dose and why do patients develop fatigue. She also wants to know if a "severe fatigue" could last several days. A higher incidence was reported with the second dose of the vaccine with adults and adolescents. No information on how long the fatigue would last. The outcome of the events nausea and vomiting was resolved on 16May2021 and fever was resolved on an unknown date. Outcome of the severe fatigue was recovering and for the event patient slept for about 16 hours a day, it was unknown. Follow-up attempts are needed. Information on Lot/Batch number is requested.

Pt. received COVID-19 vaccine on 06/05/21 and developed a mild fever on 06/06/21, but had not had a fever since that day when coming to the ED on 06/10/21. On 06/07/21 while the pt. was at school pt. became dizzy and pupils dilated. Pt. was picked up from school and rested for 3 hours and she did not remember how she got home or how she got to the school nurse..Pt.in ED for similar symptoms 6/7/21 and 6/9/21 before coming again on 06/10/21 with a negative work up. Pt. has been on school zoom meetings and has been looking at pillows and thinking they are people and they were moving and talking to her. Pt. walking into walls, trouble walking and intermittent confusion and multiple episodes of conversations that she does not recall and time periods which she can not remember. Pt. was transferred to a higher level of care in another facility.

30 mins after IM injection: Left arm tingling 45 mins after IM injection: Left arm, Left shoulder, Left upper back tingling, Headache, chills, fatigue

Systemic: Anaphylaxis-Medium, Systemic: Rash (other than injection site)-Mild, Systemic: Other- wheezing, shortness of breath, coughing-Medium

Per paramedic, "Pt's mother told staff "my daughter's not feeling well." Paramedic was notified and pt was unc when he arrived. Pt was taken to the medical tent via w/c. Pt regained consciousness and was placed supine with legs elevated." RN was present when pt transferred to cot without assist. Pt was talking, accompanied by mother who states this happens every time she gets blood drawn or has a vaccine. B/P at time of incident 119/77 HR 91, 98% O2 Sat, at 5min 114/76 HR 77 100% O2 sat, at 10min. standing B/P 110/73, HR 76, O2 sat 99%. A/O speaking in full sentences, sitting up drinking water. Skin color pink. Pt monitored for 45 min. Stable at d/c by paramedic. Post vaccination instructions given.

17 yo F in post vac are reports nausea, dizziness, headache 4 mins after vaccination. Denies other s/s, speaks clear and complete. No respiratory distress noted. Two set of vitals taken, WNLs. . Monitored for 30 mins, s/s continued and have increased, post vac nurse recommended medical attention. Mom declined EMS transport. Mom stated she would take pt to a local urgent care.

Fatigue; Headache; Fever; Dizziness; This is a spontaneous report from a non-contactable consumer (patient). A 17-year-old female patient (not pregnant) received the second dose bnt162b2 (BNT162B2, lot/batch number and expiry date were not reported), via an unspecified route of administration in left arm on 29Jan2021 13:00 at SINGLE DOSE for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. She had her first dose of bnt162b2 on 08Jan2021 in the left arm. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 29Jan2021 17:00, the patient had deadache, fever, dizziness and fatigue. No treatment was reported. The outcome of events was recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Flushing, sweating, anxious, tingling in ears, nausea, blurry vision. Vitals within normal limits. Patient stabilized.

Written by the patient and guardian: " 8-10 minutes after shot, complaints of light head an throat closing up. Removed mask for fresh air, no relief. Went to get up for water, immediately for light headed, pale face, checked-out look in eyes. Body went limp, set 17yo in chair, still was light headed and lethargic. Laid 17yo down on floor, administered water. Vision came back dizziness went away. remained seated for another 15minutes. Continued hydrating w/ water, other symptoms diminished." From Dr.: "Witnessed patient pass out in chair, within 10-20s was helping caregiver lower patient to the floor and patient had come to. Increasingly alert. Endorses above narrative, as well as not having eaten or drinking much today, "maybe an apple". She does not have a history of vasovagal syncope. Patient Pulse at 65, normal breathing, no distress, no signs of injury. Overall episode appears to be vasovagal syncope. Patient asked to drink water and remain at the vaccine center an additional 15-20 minutes for observation. After 15 min patient feeling back at baseline. No further medical intervention.

Approx 3 hours after vaccination, patient did describe headache. About 12 hours after vaccination, patient was describing trouble swallowing and felt like her "throat was closing". No trouble breathing was noted. Patient went to local ER and was treated with ketorolac for HA and diphenhydramine. Patient was back to normal self 15-20 minutes after diphenhydramine. No further problems reported 12 hours after this.

A few hours after I had chills and a really bad body ache. I could barely move without hurting. I couldn't go to work. I had a low grade fever. Tylenol helped. It was better after the second day. For the second dose the symptoms were similar. My arm is still sore.

Pt is complaining of shortness of breath and dizziness. As well as typical post-covid vaccination symptoms (i.e. aches, fever/chills). All symptoms started roughly noon - vaccination was around 4PM the previous evening.

Fever of 103 F, received Tylenol, then developed tonic-clonic seizure activity for about 20 minutes (received 10mg intranasal midazolam and 0.5mg buccal clonazepam while awaiting EMS)

Chills; body aches; This is a spontaneous report from a contactable consumer (patient parent). A 17-year-old (17-year-old age at vaccination) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on 27Jan2021 01:00 PM at single dose in left arm for COVID-19 immunization at clinic. Medical history was none. The patient was not pregnant at time of vaccination. No other vaccines received by patient within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. No Allergies to medications, food, or other products. Concomitant medication was not reported. The patient previously took (at age 17-year-old) first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: E1014D) on 06Jan2021 in left arm for COVID-19 immunization. The patient experienced chills, body aches on 28Jan2021 01:15 AM. No treatment received for the adverse events. Since the vaccination, it was unknown whether the patient been tested for COVID-19. The outcome of events was recovering. Information on the lot/batch number for 2nd dose has been requested.

itching one arm in one spot with brief throat itching. Pt felt much better with parents driving her. Called family on phone daughter doing better went to store

At approximately 49 hours after the first dose, patient experienced unusual sudden tiredness, soreness at the injection site, visibly flushed face and sensation of heat emanating from the face. No treatment was given. All symptoms were resolved within 8 hours from onset.

Felt scratchiness in back of throat. Denied difficulty breathing. Chest clear, no wheeze. BP 118/76, PO2 97%, Pulse 71. Patient given Benadryl 25 mg PO x 1. Within 15 minutes felt normal again.

Patient was dizzy and nauseous. She felt heaviness in her head. Her vitals WNL. She had not yet eaten and was given Coke and a snack. Patient's symptoms resolved within 15 minutes.

17 YEAR OLD PATIENT: AFTER RECEIVING VACCINE PATIENT SAT IN OVERVATION AREA, UPON SITTING DOWN EXPERIENCED DIZZINESS, SHORTNESS OF BREATH, FATIGUE. PATIENT DEMONSTRTING RAPID EYE MOVEMENTS, RESPONSIVE TO DIRECET QUESTIONS AND TO PAINFUL STIMULI THOUGH UNABLE TO SPEAK IN FULL SENTENCES. DENIED CHEST PAIN, COUGH NAUSEA, VOMITING. MOTHER STATES SIMILIAR BEHAVIOR WHEN SHE DEVELOPED BLOOD CLOT IN THE PAST. PATIENT THEN STATED FELT LIKE THROAT WAS SCRATCHY.

After 2nd vaccination, client felt throat itchiness and swelling, and tongue swelling 15 minutes after. Client and guardian verbalized same adverse effects after 1st dose, and risks explained prior to 2nd dose vaccination. Client had difficultly swallowing and guardian gave client oral Benadryl which decreased some symptoms. No s/sx of resp distress, no SOB. client and guardian verbalized they did not need to be transferred to ER for further evaluation. Client and guardian left clinic @ 2:45 PM

Extreme chills, fever (lasted up to 24 hours), exhaustion, huge swollen bump over shot injection site, rash down left arm, swollen lymph node in left armpit where shot was administered

The day after the vaccine- chills and headaches-lasted for 3 days The symptoms worsened slowly & on 03/10/2021 presented: sore throat, cough, diarrhea, chest pains when coughing. Patient was tested for COVID-19 (PCR), for Strep (RST & THROAT CULTURE), Influenza A& B, EKG, CBC and Basic Metabolic. Patient was treated with AMOXICILLIN for possible Strep until culture was available, ALBUTEROL INHALER & DEXAMETHASONE for bronchitis. *** This patient was Positive for COVID-19 in August 2020. She had the same symptoms as in March.

Began having seizures; Presented to the ER on 17 March 2021 for headache with blurry vision; Presented to the ER on 17 March 2021 for headache with blurry vision; Also had persistent nausea and subsequent vomiting; Also had persistent nausea and subsequent vomiting; Fever X1 to 100.4F on day of presentation/no further sz; This is a spontaneous report from a contactable physician. A 17-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly in right arm on 08Mar2021 (lot number: EN6206) at single dose for COVID-19 immunization. Medical history included headache and irregular periods, ongoing hospitalization. No known allergies. Concomitant medications included birth control pills. No other vaccine in four weeks. No COVID prior vaccination. Vaccine received during existing hospitalization. The patient began having seizures (hospitalization prolonged, life threatening) on 16Mar2021 12:00, presented to the ER on 17Mar2021 for headache with blurry vision (hospitalization prolonged, life threatening) on 16Mar2021 12:00, also had persistent nausea and subsequent vomiting (hospitalization prolonged, life threatening) on 16Mar2021 12:00, fever x1 to 100.4F on day of presentation/no further seizure (hospitalization prolonged, life threatening) on 16Mar2021 12:00. Clinical course: Presented to the ER on 17March2021 for headache with blurry vision. Patient reported symptoms for 1 day prior. Also had persistent nausea and subsequent vomiting. Presented to the ED at 23:00. Began having seizures. EEG shows localized to the occipital region. Fever X1 to 100.4F on day of presentation no further sz. LP shows 1 WBC, Gram stain negative. Cultures negative. HSV pending. On ceftriaxone and acyclovir. Continues to have focal sz on EEG now on 3 AEDs. MRI with contrast negative. CBC unremarkable. CRP elevated to 0.8 (normal less than 0.5). Tox screen negative. COVID tested post vaccination: Nasal Swab (SARS-CoV-2 Cepheid) with result of negative on 17Mar2021. Therapeutic measures were taken as a result of all the events which included treatment with IVIG, Antibiotics, Steroids, Antiepileptics. The outcome of the events was not recovered.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported events cannot be completely excluded based on temporal association and known drug safety profile. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Body aches, feelings of hot cold, dizziness, temp 101, chills, mild joint pain, resulting in loss of sleep. She drank fluids(some electrolytes), and took two Advil.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Additional Details: patient became nauseas, lightheaded, and had mild flushing post administration. patient was given water and was sat down. patient recovered fully 10 minutes later and left with no further issues.

Client felt light headed and diaphoretic within 15 minutes of vaccination. Was transported to Hospital.

Started to have typical flu symptoms night of 2nd vaccine, also followed with dizziness, nausea, and lastly small bumps of a rash developed over chest, neck and back.

Patient woke up in the middle of the night because her nose was spontaneously bleeding She had a slight headache the next day. She has never had a nosebleed before.

Pt had reaction in the waiting room. Pt became pale, diaphoretic, passed out and had brief seizure x 3-5 seconds. She suddenly became aware again with no recollection of what happened. She continued to be pale and diaphoretic and c/o confusion and blurry vision. Pulse ox 98-100, HR dropped to 40's and BP 90/60. Squad was called, they assumed care and transported pt to ER with her mother present.

Fainted for 2 seconds. Sweating. Pale lips but the color got back on after few minutes. Tingling. Could not lift up her arm (but could feel squeezing thumb). Shaken hands and feet. Lied down on the ground around for 10 minutes and elevated feet. Had her to keep breathing in/out. Kept drinking water and gave orange juice. Called 911. EME arrived and took care of patent. Pt didn?t want to ride on the ambulance and said fine. Was able to walk in the end. Left the scene with her mom.

6 am following day (4/6) after injection on 4/5/21, my 17-year-old daughter complained of sore right arm (injection site), tinnitus, syncope, nausea, fever. Day before had also been treated for vaginal yeast infection. Treated with miconazole and fluconazole (tablet and vaginal cream). Also complained that her ovaries hurt. She self-administered Motrin and applied heat. Went back to bed. Has rested without waking, suspect fatigue as well.

Presented at 0905 for vaccine. 0912: Staff were called to the patient vaccine area. Patient did seem vaso vagal post vaccine (loss of color and diaphoretic), patient then appeared to have a Grand Mal type seizure with arm contracture and vomiting x4. Patient was unresponsive for around a minute. Only meds patient: BCP Patient accompanied by her mother. o2 98% HR 81 BP taken at 920 130/80. 0935: Patient seemed post-dictal, very sensitive to touch and disconnected. As per Mother, the patient had a history of a prior Grand Mal seizure 4 years ago; that was never worked up. Patient complaining that she is "Very Lightheaded." Spoke with patients primary PCP MD, she stated that it was not likely a seizure and that it was extreme vaso-vagal response and that the patient could go home if now drinking and responsive. Patients mother also spoke with PCP and I gave her the option to decline EMS or to go be evaluated. Patients mother chose for her to be evaluated. EMS was contacted by the local police who were working the vaccine clinic. Vitals taken by EMS: BP 127/61 Blood Glucose 97 0955: EMS arrived / Patient transported to ED.

Within 5 minutes of receiving vaccine, patient became lightheaded and diaphoretic. Patient vasovagal. Feet were propped up, patient returned to baseline with 5 minutes of episode. Was released into the care of her boyfriend.

Pt had itching about 50 minutes after getting the Pfizer covid vaccine. Pt waited the time requested and was thankfully still shopping with her mother and brother in the store when the reaction developed. Pt was given 50mg of liquid diphenhydramine. I discussed calling 911 with the family and they said they would prefer we did not if possible. She has food allergies, which were discussed before giving the vaccine and she is used to having reactions, she also knows what anaphylaxis feels like and could tell that was not the reaction she was having. After discussing with the family and consulting with my market direction I decided to not call 911 immediately but let them know that if the diphenhydramine was not helping quickly I would make the call. I observed the patient for 30+ minutes with an EpiPen on my person in case she showed any signs of worsening. She improved visibly while getting drowsy from the antihistamine. After she had stabilized for some time and the patient and her family was also comfortable with her improvement I allowed her to depart the pharmacy with a request to keep her EpiPen close and call 911 if things worsen or the EpiPen became necessary.

Pt reported having an uncomfortable scratchy feeling in back of throat. Pt has experienced anaphylaxis in past and was anxious about experiencing it again. Pt moved away from waiting area to be evaluated by RN. RN Assessed pt. Lung sounds clear, Pt denies having difficulty breathing, O2 sat remained 98% or better for the duration. BP initially 141/89 while sitting with HR at 75. Pt laid down with feet propped on chair. Vital signs reevaluated 15 min later: O2 98%, BP 118/89, HR 77. Pt still reports itchy throat but does not have difficulty breathing. Contacted on-call physician, recommended pt be evaluated at ED or urgent care. Pt parent refused ambulance; opted to drive pt to ED for further evaluation.

About ten minutes after injection, face and ears became flush and throat became itchy. Complained of mild dizziness and growing lump in her throat. Medical staff checked throat, blood pressure, O2, laid her down on cot with feet elevated. After 20 minutes of stable BP called the chief of immunology who recommended she go to Urgent Care for follow up. While waiting at Urgent Care for 30 minutes, her face, tongue, and throat became swollen, hives developed on face, and had increased difficulty in swallowing and felt short of breath. She was taken to a patient room, IV started and Epi-shot was given. Additional allergy meds were given (Benadryl and Solu-Medro). She the. Slept for the next 90 minutes. Swelling decreased and throat felt better. Monitoring for a couple hours and sent home.

At 1137am, 5 minutes after receiving Pfizer vaccine, pt c/o dizziness and lightheadedness. At 1139 pt became pale and diaphoretic, so EMT lifted her from chair, she then lost consciousness for approximately 30 seconds. Pt was placed on floor in trendelenburg position with her feet elevated on a chair. When she regained consciousness she did not recall being placed on the floor and stated she "blacked out" and was still dizzy. At 1138 EMT called 911. At 1145 EMT recorded the following vitals: BP 68/44, HR 58, and RR 16. At 1145 paramedics arrived and assumed care of pt. At 1150 paramedics took the following vitals: BP 70/50, HR 54, and blood glucose 95, and from these indications decided to start and IV and admininster a 500cc bolus. Pt O2 sat was 100% but she was placed on 2L O2 NC for comfort. At 1205 paramedics transported pt to Hospital for further evaluation.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Tinnitus-Mild, Systemic: Vomiting-Mild

Events happened about 5 mins after shot was given. Patient experienced lightheadedness, loss of consciousness for a couple seconds, uncontrolled urination, hot flashes, headache. Patient was given water and a snack to consume. After about 10 minutes of resting and consuming food, she feeling better afterwards, said it could have been to fear of getting injections, and was able to go home with her family.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hyperventilation-Medium, Systemic: Shakiness-Mild, Systemic: Weakness-Mild

Rash all over face and arms appeared 3 days later. It is now the 5th day and the rash has spread to my legs and stomach/very itchy and irritating; fatigue; This is a spontaneous report received from a contactable consumer (Reporting for herself). A 17-years-old female patient received Second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EM9810, Expiration date: not reported) via an unspecified route of administration in Arm Left on 13Feb2021 12:45 (At the age of 17 years-old) as single dose for COVID-19 vaccination. The patient medical history was not reported and no known allergies. The historical vaccine included first dose of BNT162B2 received via an unspecified route of administration in Arm Left on 23Jan2021 12:30 for COVID-19 vaccination. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No COVID prior vaccination. No COVID tested post vaccination. It was reported that patient had no symptoms after the 1st dose. On 16Feb2021 she had fatigue (the first 1-2 days after getting the 2nd dose of Pfizer) that got better. Rash all over face and arms appeared 3 days later. It is now the 5th day and the rash has spread to legs and stomach. It was beginning to get very itchy and irritating. Patient was treated with hydrocortisone 3-4 times a day and it was not of much help. The outcome of the events was not recovered.

Patient had anxiety prior to receiving vaccine and after. She said she felt very nauseas and wanted to puke. Was having trouble breathing. Patient did end up puking a few times. She was sweating and overheating, her tongue was starting to go numb, but she said her throat was not closing up. Her lips started to become white and she said she was having trouble seeing. her vision came and went at different times. EMS arrived and did diagnose her with an allergic reaction, gave her benadryl, and an ice pack. And sent her home.

Flushing/Sweating, Dizziness, Nausea. BP 84/50 HR65 RR18, then 3 minutes later improved to 104/64, HR88, RR18. Received water, symptoms resolved, discharged with father

About 20 minutes after receiving the shot I got drowsy. About 30 minutes to an hour later I started having mild stomach cramps similar to menstrual cramps. I later found out I had menstrual bleeding (about 2:30 PM). This was unnatural for me because I have an IUD and have had it for 9 months, so I haven't been getting PMS like cramps or my cycle for the past few months.

Anaphylaxis (hives, oropharyngeal swelling, cough, shortness of breath) 20 mins following vaccine administration. Patient given epinephrine at vaccine site 20min after symptom onset with significant improvement in symptoms including improved pharyngeal swelling and resolution of hives. Patient presented to the emergency department 1.5 hours following onset of anaphylaxis with mild cough and mild pharyngeal swelling for observation.

less than 10 minutes after vaccine administration patient was kneeled over on floor bent over on chair . extremely pale, feeling lightheaded, head pounding, ears with sudden onset of lots of pressure. mother said never reacted to vaccine like this before. called EMTs they said her blood pressure was fairly low and wanted to take her to the ambulance for further evaluation.

Within about 20 minutes of administration, the patient reported feeling nauseous, hot, faint, and sweaty. She stated she could "hear the lights". Her temperature was normal at 96.2 degree Fahrenheit. She stated that these same symptoms have happened before with other vaccines, Within another 20 to 25 minutes she felt better and left with her mother. I checked in 5 hours later via the phone and she was feeling better. She only reported a sore arm at that time.

Heavy sleeping, sore and stiffness in arm that was injected, chest pains and tightness of chest, nose bleeds and severe headaches

She had COVID-19 infection on January 5. She received Pfizer vaccine 3.28.2021 - er8733 lot. she was feeling well prior to the vaccine with no seasonal allergy symptoms. No nasal congestion or itchy eyes. No NSAIDs the day of vaccine. Tired 20 minutes later. She woke up 4 hour later with fever 101. Took Tylenol 5-6 hours later. No ocular swelling at that time. had some nausea that evening and some abdominal pain. No muscle pain. Some chest tightness that evening. The next miring was very hot and nauseated and then vomited. Two days later swelling around eyes, not too itchy. Swelling was more severe in April 4. the swelling is slightly improved over the last week. On April 4, antecubutal fossa were itchy and red. lasted 1-2 days. No runny nose, sneezing or itching. Low grade fever lasted 1 hour. fatigue lasted a few days. No muscle or GI symptoms. No NSAIDs, but Tylenol initially. no sore throat. No mucous membrane involvement. No leg swelling. No change in urine output. No joint pain. No headache. No vision change. No bleeding gums. No hives. No enlarged lymph nodes. No SOB. No chest pain. No change in bowel habits. Energy level good. No night sweats. SAR symptoms well controlled. Mild swelling at left arm injection sight that lasted 1 day. swelling is worse in the AM when waking up; both upper and lower eyelids.

The shot was given on Friday around 1 pm. Blurry Vision immediately after vaccination, then felt fine until 7 pm. At 7 pm she fainted at Lacrosse practice. The following day, Saturday, she fainted at work and was sent home. Sunday, she slept most of the day. Monday, she fainted at school and was sent home. Symptoms have been feeling of her heart racing, blurry vision, fainting, weakness, and major fatigue. No fever.

Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient fainted in waiting are 5 minutes after shot. Patient's muscles stiffened up and she hit back of head on shelf. Pharmacists lowered patient to recovery position on floor, where pt recovered consciousness and relaxed. Patient's mother said that patient has vaso-vagal responses to shots and that she was having one of those. Patient was well and was able to leave without further assistance.

Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Additional Details: Patient was close to vomiting, benadryl was given, patient recovered.

Patient arrived with mom for Covid vaccine at 12:48 pm. Mom reports a history of fainting so nurse decided to administer vaccine with client lying down. Vaccine was administered and client immediately stiffened arms and appeared to seize while her eyes rolled back. Nurse reported she turned the client onto her side and she "came to within 20-30 seconds." She reported blurry vision but could read when asked to do so. She quickly became alert and oriented. Her mother reported that she had a previous episode one time in the past year with painful menses. Her vitals remained stable but each time she attempted to stand up, she reported feeling "sick." She developed a headache within minutes of the vaccine and took 2 Tylenol while still there. Client left with parent to follow up at hospital.

Sore arm after shot. Fever, body aches same night into next day. (as expected) Breakthrough bleeding started 2nd night after shot with full blown period starting 3rd morning after shot. She is on the pill, did not miss a dose and has never had breakthrough bleeding. We are on day 3 so no known outcome resolution of bleeding.

At approximately 6:20pm on 03/30/2021 patient during 30 minute observation (high risk due to immunosupression) had dizziness without syncopy. On assessment at 6:20 PM HR:121, BP:102/70 R:18 O2:99%, patient was AA&Ox4, answered questions correctly. 6:30 HR:83, BP:90/70, R:18, O:99%. Patient states: "I can not drink water." Patient appeared less alert and hard to rouse, Transportation to ER was advised repeatedly. Mother stated: "I don't want to take her to ER, because it is too dangerous for my daughter because she is on steroids. We have been in ER 3 weeks ago due to migraine and they check all labs." Mother refused to call 911 and said she would transport the patient to ER of Hospital.

On March 27, 2021 at 11:30pm started to not feel well, went to sleep woke up on and off through the night with chills, on march 28th felt nauseous on and off throughout the day, also had a slight fever of 101°F took tylenol and it helped

1705- Pt passed out right after vaccine. Pt regained consciousness about 3-5 seconds later, stated that she couldn't hear anything. Pt moved to the observation area in a wheel chair. 1715- Pt passed out again, ammonia inhalants used. Regained consciousness 3 seconds later. Pt sweaty. Ice placed to back of neck. Pt moved to cart. First set of vitals @ 1717: Spo2: 100% HR: 53 BP: 83/42 Water and snack given to pt. Second set of vitals @ 1720: Spo2: 95% HR: 54 BP: 88/48 Third set of vitals @ 1726: Spo2: 97% HR: 64 BP: 102/64 Pt sitting up and talking with staff an mother, color in face improving. Pt states she is starting to feel better. Fourth set of vitals @1732: Spo2: 99% HR: 67 BP: 103/66 Pt sitting at 90 degrees, eating and drinking. States she does not feel nauseous. Last set of vitals @ 1537: Spo2: 100% HR: 62 BP: 94/63 Per mother she normally faints with vaccines. Pt states she is feeling much better. Reminded pt and mother to keep up with fluids.

pt looked pale 10 minutes after vaccine went out to check on him he was getting faint and lips looked purple, was NOT having breathing problems and BP was normal at 104/54, called 911 patient was very clammy and sweaty, stayed with patient until paramedics arrived, patient was feeling much better a little before paramedics arrived, but they decided to take him to hospital

immediately after vaccine patient asked if she "could sit for a minute"; became pale, diaphoretic and limp in the chair; responded immediately to spirits of ammonia and position change; patient given oral fluids and responded well; patient observed for 45 minutes before being allowed to leave vaccine clinic

Dizziness, mild sweating, and a temporary loss of hearing a few minutes after the shot before brief LOC. Mother reported "eyes rolling up" and a respiratory gasp. Rapid recovery with fully orientation on the floor. VS stable in observation. No nausea or visual changes reported by the patient. No orthostasis.

Patient is a 17 year old female who has completed a 30-minute observation period with the following signs and symptoms of an adverse reaction: loss of consiousness. Pfizer-BioNTech COVID-19 vaccine # 1 in series administered. Parents states that patient become pale and dizzy 1 minute after she received covid vaccination , Patient had a syncopal episode in the hallway, unknown if patient hit her head against the floor, no bruises, soreness or redness notice Patient become alert and oriented x 4, pale, diaphoretic, Patient states that she didn't breakfast.Also Patient mentioned that she is afraid to needles. Action(s) taken: Vital sign at 0814: blood pressure ; 75/34, heart rate: 65, respiration ; 16, Spo2: 99 % Repeat Vital sign at 08:28: blood pressure ; 85/44, heart rate: 65, respiration ; 16, Spo2: 99 % Repeat Vital sign at 08:31: blood pressure ; 97/58, heart rate: 66, respiration ; 16, Spo2: 99 % - Patient denies chest pain ,shortness of breath, nausea vomiting, diarrhea, abdominal pain, difficulty swallow, headache, dizziness, or vision changes - Patient was able to tolerated fluids intake well. Action(s) taken: Transferred to higher level of care, ER Patient and parents advised to discuss second dose considerations with a clinician

1325- Pt presented to observation room, mom was supporting her as she walked. I got to the patient and supported her to the ground as she started to fall. Pt did not lose consciousness, appeared diaphoretic and pale, stated nauseated and didn't feel good. Mom said she has done this in the past when has had injections or blood draws. Laid pt with feet up on a chair. Ice pack placed on forehead. Answering questions appropriately. 1328- BP 112/72, HR 68, RR 20 1330- pt stated feeling better and sat up slowly 1333- felt well enough to sit on the chair 1338- pt and mom opted to leave premises, pt appeared neurologically intact, stable and walking independently

She began to have a headache the day after the vaccine was given. The headache is on the top of her head. She reports that the area feels heavy. Doesn't normally have headaches like this.

Severe headache, dizziness, nausea lasting approximately 45 minutes woke from sleep on night of 4/11/21. Improved with tylenol. Milder headache/dizziness for one day following, no medication needed.

General fatigue, feeling slightly unable to speak or text in clear sentences (i.e., patient said she feels "loopy"), coughing for a little while, chest (lungs) feels heavy

Dizziness, Syncope; Cough abd pain, sweathing. BP 101/53, HR 60; RR 24 -- > 119/59, 67,20 -- > 94/67, 57. Given OJ and water, pt felt fine after drinking water and OJ. Patient stable and released from vaccination site.

Hx: Anxiety Allergy: Amoxicillin; Flushing/sweating, BP 104/61; HR 65; RR 18. Pt c/o "I feel like I'm going to faint". Pt denies eating x24hrs. Pt D/C w/ , mother and no c/o @D/C, BP 112/61, HR68, RR16. Patient stable and released from vaccination site

Woke up around 2AM the morning after the vaccine was administered and noticed pain in hands when washing hands. Woke up officially around 9AM. Entire body hurt, most notably headache, backache, and neckache. Pain was intense, took Ibuprofen and muscle relaxer. Stayed in bed in the dark for most of the day because of pain. When standing, dizziness and weakness, fell over once. The pain finally subsided enough to function close to 7PM, disappeared completely by the following morning.

Ms. Young was observed post Covid-19 immunization for 15 minutes. During the observation period, she experienced an adverse reaction with the following symptoms: Facial rash/bilateral checks. No itch. Warm to touch. Assessment : Patient left after check out in while in her car noticed the rash/flushed face on her face. Patient returned at 12:23pm and rash was noticed by RN to be red to the cheeks bilateral and warm to touch. It was noted that rash followed the outline of the patient's mask. Patient reports she has worn the mask before with no issues. Mask no washed in the past 2-3 days per patient. Alert and oriented. Patient reported itchy throat at 12:35. No difficulty swallowing. At 12:51 patient states she no longer has an itchy throat. Rash in still present. Not worsen in appearance. Patient reports no other symptoms. Patient stable and orientated x4. Walked patient out to door at 12:58 and gave Pfizer information sheet along with symptoms to look out for such as worsening in rash, difficulty breathing, swelling of the face and neck, fast heartbeat and dizziness or weakness. Actions taken: Vitals sign taken VAERS form completed Paramedic on site. Vitals Signs at 12:36, BP= 116/64 HR = 76, 02 = 100, Temp: 97.9F (Temporal) ,Vitals Signs at 12:55, BP= 119/54, HR = 72, 02 = 100. Medications administered: Loratadine (Claritin) 10 mg by mouth. Time: 12:25 pm. Administered by, RN. Famotidine (Pepcid) 20 mg by mouth. Time: 12:30. Administered by, RN, Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home. Instructed to follow up with PCP for evaluation for second dose. Instructed to call 911 for trouble breathing, rapid heart rate, dizziness, swelling of tongue or throat. The Patient was provided with Vaccine Information Sheet and instruction to access the system. Immunizations Administered, Name, Date Dose VIS Date, Route Pfizer COVID-19 Vaccine, 4/19/2021 12:00 PM, 0.3 mL 2/25/2020 Intramuscular, Manufacturer: Pfizer, Inc, Lot: EW0164, NDC: 59267-1000-2.

Rashes all over the body with medium to large size blots, redness and raised. The skin has a rough texture to the touch. Headaches, tiredness, chills, and light nausea. Lack of air, and chest pressure, with difficulties to swallow.

Felt dizzy at work the next day after the second shot. Passed out and then was sitting down and I felt nauseous. I threw up 5 times and my arms started to get numb. I had a fever when I got home and I couldn?t move because my body hurt so badly. Migraine and dizziness has been persistent ever since and is interfering with my daily life. Been treating with tylenol which helps a little but not completely. As soon as I stand up and move I feel like I?m going to pass out.

Patient not seen in office. History obtained via phone from father of patient and patient herself. Very early on 4/19/2021, 8hrs after receiving her 2nd Pfizer COVID-19 vaccination, patient began developing nausea, chills, sweating, fever and malaise. Highest fever was 102.3', with symptoms treated with Advil 600mg. Had x1 episode of vomiting that day, none since. The next day 4/20, patient woke up with new-onset lip swelling, progressing to periorbital swelling and swelling of her facial cheeks & rash. She then began having a cough with some throat tightness with some mild discomfort with breathing in her throat, but no chest tightness or wheezing. Tongue not swollen per patient. Benadryl 25mg PO given multiple times and patient used her Albuterol MDI a few times as well, which helped. She continued to have fevers to 101' throughout the day, treated with Advil again. At night, patient then developed semi-itchy red "hives" on her legs. Per patient, she didn't feel she needed to go to ER for her symptoms or throat tightness/breathing issue. She was still drinking & urinating well and had been consuming light solids foods. The same day 4/20 in the afternoon, patient was prescribed over the phone Prednisone 60mg PO x1 which she first took after 5pm, with tapering dose over the next 4 days, in addition to increasing Benadryl to 50mg PO and starting Qvar 80 MDI BID, while using Albuterol prn. Via phone call to father this morning 4/21, patient reportedly slept well last night and woke up this morning with significantly less symptoms. No longer having throat tightness/breathing issues, with much less periorbital/facial swelling. Still fatigued but no longer having fevers, either.

Patient received her 2nd dose of COVID (Pfizer). She walked out of the immunization room to wait in the store, made it about 2 aisles over, and fainted. Patient's father and the Pharmacist immediately got to her side. She came to within less than 1 minute. In the meantime EMS was called and the Pharmacist waited with the patient until they arrived. EMS looked over the patient and patient was able to leave on her own after waiting out the nausea and dizziness that had occurred. Patient also reported a headache which was most likely from hitting her head on the way down.

emale client received her first dose of Covid Vaccine (Pfizer, Lot # ER8729, Expiration date: 07/31/2021) at 1132. This minor client, accompanied by her mother proceeded to the observation room for her 15 minute wait period. Co-lead RN, was present in the observation room assessing another client. At 1137 this client's mother loudly voiced from the back of the room, "she's feeling dizzy" and co-lead observed client was hanging her head. Co-lead and EMT1 hurried to her side, and client stated she was feeling lightheaded and dizzy and was suddenly pale and diaphoretic. EMT1 immediately transferred her from chair to floor with full assistance to prevent a fall/injury. Client was placed in trendenlenburg position by elevating feet and placing them on the chair. Client was unresponsive for about 15 seconds until she regained consciousness and returned to baseline mentation. Client verbalized she "blacked out" and did not remember being placed on the floor. Client denied pain and respiratory distress. EMT1 called 911 at 1138. Client and her mother deny she has any medical issues, allergies, medications, or previous incidence of syncope. At 1145, first set of vitals taken by EMT1 indicate hypotension and bradycardia as follows: BP 68/44, HR 58, and RR 16. At 1145 paramedics arrived and assumed care after receiving report from EMT2. At 1150 medics took VS with BP 70/50, HR 54, and blood glucose 95, and determined they would start an IV to administer a 500cc bolus for dehydration and to improve BP. Client was also placed on 2L O2 for comfort, no desat noted. At 1200, medics advised client's mother and co-lead they would transport client to the Hospital for further evaluation. Medics departed at 1205 to transport client to the hospital.

04/21/2021 11:48 AM Patient says she was lighted headed and dizziness. wasnt speaking dropped her phone and was not aware. BP WAS 79/37 Pupils were fixed with some movement.. mother was outside, called in. mother had stated earlier that she was afraid of needles. felt clamy and sweaty. patient taken to ER in wheelchair with mother for evaluation

Fell to floor from chair in observation area. OC related to vaccine administration. Pain in right cheek. Pain level 2.5/10. Vaso-vagal response post vaccine injection. Vital Signs: BP 100/60 HR 85 Resp 20 O2Sat 98 , Skin Signs: Cool and dry, Clammy, Circulation: Cap refill <2sec, Respiratory: Breath sound clear bilaterally, Initial Treatment: Water/observation/elevated les bilateral. Assessed/evaluation by Dr. 10:25 AM, Vital Signs: BP 100/72 HR 85 Resp 20 O2Sat 72, Skin Signs: Cool and dry, clammy, Circulation: Cap refill <2sec, Respiratory: Breath sound clear bilaterally Follow up Treatment: Mask Oxygen administration for 10 min. 10:25-10:35 AM. Ice pack to right cheek, approx. 4 L and reduced to 2 L/min\, 10:35 AM\, Vital Signs: HR 98 Resp 20 O2sat 99, Skin Signs: Cool and dry, clammy, diaphoretic Circulation: Cap refill <2sec, Respiratory: Breath sound clear bilaterally 10:45 AM, Vital Signs: BP 120/82 HR 76 Resp 20 O2Sat 97, Follow up Treatment: 10:45 skin warm and dry, alert and oriented x3. Cap refill <2sec ,Notes: Recommended parent to contact peds office for injury to right cheek. Continue to maintain good hydration at home the rest of the day. Home with father at 10:55 AM

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Headache-Mild, Systemic: Hyperventilation-Medium, Systemic: Nausea-Severe, Systemic: Shakiness-Medium, Systemic: Tachycardia-Mild, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Mild

Left arm sore. Severe migraine headche with blurry vison in left eye( vision corrected later in the day) Onset of mentrual cycle with severe abdominal cramping , nausea, heav bleeding and headache.

Left arm ache, sore with slight bruising. Headache and mild fever. Pain ful menstrual cycle with abdominal cramping and heavy bleeding with the cycle lasting for 6 days ( more than normal ).

After receiving vaccine, patient became light headed and passed out sitting in chair. diaphoretic and clammy. Heartrate 60, BP 60/29,SPO2 100%. Medical response called, patient taken to ER, accompanied by mother

At 1143 - 17 year old female was sitting with her mom, pt advised staff that she was feeling dizzy. Pt states the room was spinning. Pt was assisted to wheelchair and escorted to designated private patient area. Pt was pale and diaphoretic but was alert and talking to staff, pt was assisted to remove her sweatshirt and assisted to lay down. Pt instantly stated she felt better after laying down. Pt provided wet cloth for comfort and skin color return to WNL . Pt had small sip of water and stated she felt much better. Pt advised she had only eaten two small donut holes and did not drink water prior to arrival at the clinic. Pt skin returned to normal warm and dry, VSS, AOx4 and pt stated she felt much better and was ready to go home. Pt mother will continue to monitor pt and ensure she continues to hydrate and eat after leaving the site. 1145 VS Bp 94/60 HR 51, 16RR 100% 1150 VS Bp 102/64 HR 60, 16RR 98% 1155 VS Bp 102/68 HR 69, 16RR 98% 1200 VS Bp 104/68 HR 73, 16RR 99% sitting

COLD SWEATS, DIZZINESS, DROWSINESS, BP WAS TAKEN 74/44, THEN 5 MINS LATER 99/60, PT WAS LAID DOWN TO PREVENT FALLING, PT WAS NERVOUS AND ANXIOUS

One day after the second dose I felt tired, weak, cold, and with a sore arm. After, I took 3 Tylenol capsules to feel better. Today my left arm which I got the vaccine in, feels itchy and my hand is swollen and red. Now my left feet is starting to feel itchy and swollen-red.

2:00 am: chills 8:30 am: 102.2 fever with chills and throbbing headache fever continued throughout day

i couldnt sleep, woke up many times with chills and a really bad headache, the whole day ive been sick to my stomach and my head hurt. i even threw up a lot

Daughter tested positive for covid on 2 separate tests.; fever 5 hrs later; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer reported for his daughter. A 17-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown, via an unspecified route of administration on 09Apr2021 as a single dose for COVID-19 immunization. On an unknown date, the patient started therapy with Trumenba (MENINGOCOCCAL GROUP B RLP2086; Suspension for injection, Lot# and expiration date not reported) via unknown route of administration as single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in Apr2021 (reported as 5 hr. later vaccination), the patient experienced fever. It was reported that the patient (daughter) tested positive for covid on 2 separate tests. Patient wanted to clarify whether she gets covid on Trumenba. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

After only an hour outside in low 60s weather, I had felt symptoms similar to heat exhaustion. My vision got extremely spotty, and couldn?t see much. There was a loud ringing in my ears and everything else sounded muffled. I felt dizzy and my skin felt like tissue paper. It faded after I went inside and got water. However, I still have a headache, 6 hours later.

After vaccination patient described stomach hurting, nausea, sweating, and loss of hearing. Patient felt immediately better after moving up from chair and being transferred to Med OBVs at 17:18. First set of VS were taken at 17:21, HR:83, RR:20, BP: 121/68, SPO2: 98. Patient then stated that she had not eaten a meal before the vaccine, only a chewy bar. Second set of VS were taken at 17:28, HR: 89, RR: 20, BP: 116/67, SPO2: 98. Patient stated she felt fine and was comfortable heading home, last set of VS were taken at 17:45, HR: 82, RR: 20, BP: 112/63, SPO2: 98. Patient was released at 17:45 with her father.

Patient had flushing/sweating, dizziness, anxious, sweating. Low BP 84/46 -- > 116/75 -- > 121/82. Patient stated did not eat since 4/24/21 6PM. Patient stable, released from vaccination site.

At 2am 4/22 patient started to feel sick and sent a text that I didn't read until 630 as I was asleep. She had severe muscle aches, hurt to move, hurt to breathe and felt like she was having a heart attack. She felt like she might pass out and had some blurred vision. At 630am, I saw her texts and immediately brought her 2 tylenol and a large glass of water. She went back to bed. She woke up around 10:45 and was feeling decent except for a headache but no fever or anything so we went to try on some Prom dresses. At the dress shop, she collapsed and had a seizure lasting around a minute. She lost her bladder and was completely confused and incoherent. She's never had a seizure before. I scooped her up, brought her to the ER where they ran every test and scan imagineable. Full blood work up and cultures, a chest xray, a CT scan of her brain and lungs. Her temp was high 103-104 and she had full body chills and a pounding headache. Her BP kept dropping and got as low as 81/36. They threw 2 bags of IV fluids into her and admitted her to the hospital. She had also developed a heart murmur. Over the course of the night, her BP stabilized but her temp continued to spike and come back down with Tylenol/Ibuprofen. She also had IV Tordahl for the headache. Her inflammatory markers were high at 15.3 which we were told should be less than 1. They reran labs in the morning but everything can back really low which they felt was a dilution effect from all the fluids so wanted us to follow up with her primary care on Monday. On Saturday night, he lymph nodes were swollen to the size of ping pong balls but have since slowly reduced in size although still there. Her labs were better from discharge and her white blood cell count was within range and her inflammatory marker was down to 1.7. Her blood sugar was a little low. She did pass out and have seizure like response to giving blood in the doctors office, lost bladder control again, shot pupils, etc. She is still stuttering over words, has some short term memory retention and has some motor function issues which they think is a result of the initial seizure and should resolve itself over time. Her liver function tests were totally normal in the hospital but are a high now so they will be checking her out again next week.

ON 4/21/21, SHE BEGAN TO EXPERIENCE SHORTNESS OF BREATH, COUGHING, CONGESTION, SEVERE BACK ACHE, WEAKNESS, FATIGUE, FEVER, CHILLS, VOMITING, DIARRHEA. I TOOK HER TO THE HOSPITAL WHERE WE WERE TOLD THAT IT WAS DUE TO VACCINE AND SHE WAS SENT HOME WITHOUT MEDS. SHE BECAME WORSE AND WORSE AND DEVELOPED HEART ATTACK SYMPTOMS: CHEST PAIN, WHEEZING, TIGHTNESS AND HEAVINESS IN CHEST, INTENSE BACK PAIN. WE RETURNED TO THE ER AND SHE WAS DIAGNOSED WITH PERICARDITIS. WE WERE ALSO TOLD THAT HER HEART WAS SLIGHTLY ENLARGED.

Aches and sight nausea/fatigue the day of vaccine, on day of vaccine I was 142 pounds. Two days later I was 145. Today, 5 days post vaccine, I was 147 pounds. My weight has never fluctuated this much in such a short period of time ever. There has been no change to my diet, activity level, medications or any other factors since vaccination. My weight was steady prior to vaccination. The vaccine in question was my second dose. I had no adverse reactions after my first vaccine.

Patient felt dizzy right after her vaccination, she was sweating a lot and wanted to throw up but didn't . No problem breathing . we called 911 and ambulance came and took patient to hospital for further evaluation. we called patient's dad at 3:00 pm, patient was feeling fine and got home already.

Pt received Pfizer COVID vaccine, was walking with father next to her, felt faint, and father eased her to the floor, no head or body injury. Positive pallor and diaphoresis noted, legs elevated and pt color improved with pt now alert and oriented. Assisted to upright position, onto stretcher, given 1 small bottle water po, BP: 108/68, HR: 87, RR: 16 nonlabored, SaO2: 100% on RA. Pt currently has menses. 1023: drank 1 apple juice, feeling better. 1038: BP: 94/53, HR: 64, RR: 16 nonlabored, Sa02: 100% on RA. Sat upright on stretcher, legs dangling. 1044: BP 91/58, HR: 70, RR: 16 nonlabored, SaO2: 100% on RA, feeling well, drank 2 apple juice cups, standing up. 1049: standing up BP: 84/46, HR: 62, RR: 16 nonlabored, SaO2: 100% on RA. 1100: Pt feeling well, no c/o, escorted to front door of hospital, father at side. Pt aware to drink fluids today and especially during menses. Pt is also a dancer and practices every day. Discussed hydration needs prior to discharge from vaccine clinic. Pt aware to discuss vasovagal response from this injection at next visit so pt can lay down.

patient became very diaphoretic in the observation area, her head went back, eyes closed, extremities became very rigid and patient appeared to have lost consciousness for a brief moment. RN was present at side of patient, patient was hypotensive, vitals checked BP 71/48 and pulse 54. Patient states she felt like she went to sleep, started to feel better several minutes later. EMS was contacted to evaluate and transport patient to ED.

Passed out right after vaccine; muscle aches; tired; chills; migraine; This is a spontaneous report from a non-contactable consumer (patient). A 17-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 14Apr2021 at 14:15 (Batch/Lot number was not reported) as single dose for covid-19 immunization, administered at the Pharmacy or Drug store. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Mar2021 at 14:15 in the left arm for covid-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The patient was not pregnant at the time of report and vaccination. The patient did not receive other vaccines in four weeks. The patient had no COVID prior to vaccination and was not tested for COVID post vaccination. The patient passed out right after vaccine, also experienced muscle aches, tired, chills, and migraine; all on 14Apr2021 with outcome of unknown. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.

Arm pain, slight swelling in injection site area. Swollen lymph nodes on both sides of neck, overall malaise/body aches, fatigue, light-headedness resulting in fainting episode, headache

Fever, headache, light headed, sore body, pain in shoulder where I got the shot all of which lasted for about 24 hours except the sore body which is still continuing on currently.

After receiving the vaccine on 4/26, she developed headache and temperature to max 99-100 as well as muscle pain in the arm where she received the vaccine. Progressed to diffuse myalgias on 4/27 and 4/28. Was having a slight cough that is typical for her during this time of year due to allergies, no other respiratory symptoms. Then acutely developed severe jaw pain that radiated to the throat and into her chest when she woke up on 4/29 in the morning. She had 10 out of 10 crushing chest pain.

Fainted- Started feeling sick and other common side effects after 7 hours continuing throughout the next day, and passed out at 8pm about 30 hours after the shot. And continuing to feel common side effects throughout night 2 and next day (aprox. 48 hours after shot)

Not sleeping well at night due to pressure feeling in her chest up; Not sleeping well at night due to pressure feeling in her chest up; shivers; jaw got paralyzed; she got shaky; feeling bad/ brain fog; burning sensation in her body; She couldn't talk; slight elevated temp (99.7F max); She has been off balance this week since getting her vaccine; This is a spontaneous report from a contactable physician. A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Apr2021 (batch/lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome, panic attacks, migraines and acne. The patient was not pregnant at the time of vaccination. It was unknown if there were other vaccines in four weeks. The patient did not have Covid prior to vaccination and was not Covid tested post vaccination. Concomitant medications in two weeks included ondansetron hydrochloride (ZOFRAN) taken for anti-nausea, start and stop date were not reported; doxycycline taken for acne, start and stop date were not reported. The patient previously took glycerol (GLYCERIN) and experienced allergies. The patient got her vaccine on 12Apr2021. Two nights after her vaccine (14Apr2021), she got shaky and feeling bad and burning sensation in her body. No fever at that time, but slight elevated temp (99.7F max) the day after the vaccine (13Apr2021). Mother gave her anti-nausea medication (ondansetron hydrochloride 2 mg) and within 5 minutes her jaw got paralyzed. She couldn't talk. It lasted about 30 min. Mother called ambulance and patient was brought to ER. ER didn't do bloodwork or any evaluation. ER didn't know what happened per mother. She has been off balance this week since getting her vaccine (Apr2021). She feels better this morning but she still feels off balance. Not sleeping well at night due to pressure feeling in her chest up and she shivers to get the feeling away per patient (unspecified date). Slept better last night as of 17Apr2021. No facial drooping. She can smile and lift her eyebrows. Patient had "brain fog" this week as well after the vaccine. The adverse events "she got shaky", "feeling bad", "burning sensation in her body", "jaw got paralyzed" and "she couldn't talk" resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit. There was no treatment received for the adverse events. The outcome was recovered on an unspecified date for the events "jaw got paralyzed" and "she couldn't talk"; recovering for the event "not sleeping well at night"; not recovered for the event "off balance"; and unknown for the rest of the events. Information on the lot/batch number has been requested.; Sender's Comments: Based from temporal relation of event and vaccine administration, Trismus as an event in relation to suspected drug BNT162B2 cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate

nausea; headache; began having left eye twitches and they progressed to spasms and the nose and left side of her face. It then included both sides of her face; pinching in her left shoulder; began having left eye twitches and they progressed to spasms and the nose and left side of her face. It then included both sides of her face; patient could not open her eye or control her face; her left leg had goosebumps and chills; her left leg had goosebumps and chills; This is a spontaneous report from a contactable consumer (patient's mother). A 17-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: ER8731) via an unspecified route of administration on 07Apr2021 at 15:15 (at the age of 17-years-old) as a single dose in the left arm for COVID-19 immunisation. Medical history included asthma from an unspecified date and unspecified if ongoing. Family medical history relevant to the adverse event was reported as none. Concomitant mediations included ethinylestradiol/levonorgestrel (JOLESSA) taken "to decrease her periods" from 2019 ("about two years ago") and ongoing and at an unspecified dose, cyclic, for three months straight with no placebo. Then takes a placebo pill for one week straight and biotin taken "for hair and nail growth" from an unspecified date ("she began taking within the last 6 months") and ongoing. There was no history of previous immunization with the Pfizer vaccine, there were no additional vaccines administered on the same date as the COVID-19 vaccine and there were no prior vaccinations within 4 weeks. It was not provided whether there were adverse events following prior vaccinations. On 07Apr2021 the patient experienced began having left eye twitches and they progressed to spasms and the nose and left side of her face. It then included both sides of her face, patient could not open her eye or control her face, her left leg had goosebumps and chills, pinching in her left shoulder, nausea and headache. The reporter called to report that her daughter had a severe reaction to the first dose of the COVID-19 vaccine. The clinical course was reported as follows: The patient received the first dose of the COVID-19 vaccine in her left arm. Less than an hour after receiving the COVID-19 vaccine, the patient developed goosebumps and chills in her left leg. The reporter was not very concerned about it at the time. About 9:00PM that same night, the patient started complaining of pinching in her left shoulder. The reporter was not too terribly concerned. By 9:30PM, that same night, the patient started to have left eye twitches. Then they increased to eye spasms, then the patient could not open her eye or control her face. Then, it progressed to patients nose and left side of her face. At that point, the reporter tried to contact a nurse with the health insurance advice line. She waited for 30 minutes. The patient's symptoms continued to get worse, so the reporter took the patient to the emergency room. While the patient was in the emergency room triage, while hospital staff were getting her blood pressure and temperature, her symptoms also started to involve the right side of her face. Around 10:15PM, that same night, the patient started to get nauseous and a headache kicked in. The emergency department took patient straight back to a room. The patient was not admitted to the hospital. The emergency department started an IV on the patient, and they administered Reglan, Benadryl, and Toradol to treat her symptoms. The emergency department ran blood tests, preformed a urinalysis and a CT scan. The reporter did not know what all blood testing that was done revealed; however, the reporter did know that they told her that none of the testing revealed anything and were all normal. The patient was eventually discharged from the emergency department at about 1:50AM. She was sent home with Butalbital, for headache and was advised to take ibuprofen. She was still having the twitching but not as bad when discharged. On 08Apr2021, the patient's symptoms had not completely subsided, but were significantly better. On 08Apr2021, the patient woke up with nausea, chills and a headache. The reporter expected the patient to have these side effects. The side effects continued until very late in the day on 10Apr2021. The patient never vomited, was only very nauseous. The reporter also stated that when the woman was administering the first dose of the COVID-19 vaccine, the woman said "oops" and it was not explained what "oops" meant. The reporter asked if it was possible that the patient received the dose subcutaneously and that was why she had these side effects. The reporter also stated that the second dose was scheduled for 28Apr2021 and she asked if the patient should receive the second dose. The clinical outcomes of the events began having left eye twitches and they progressed to spasms and the nose and left side of her face. It then included both sides of her face, patient could not open her eye or control her face, her left leg had goosebumps and chills, pinching in her left shoulder, nausea and headache all recovered/resolved on 10Apr2021. No follow-up attempts are needed; No further information is expected.

fever 100.9; nausea; back pain; sleepiness; chills; fast heartbeat; This is a spontaneous report from a contactable consumer (parent) reporting for his daughter. A 17-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as single dose and had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as single dose for covid-19 immunization and stated was fine after the first dose. Patient was 17-years-old at the time of vaccination. The patient medical history and concomitant medications were not reported. The patient experienced fever 100.9, nausea, back pain, sleepiness, chills, fast heartbeat on an unspecified date. The outcome of event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Headache; This is a spontaneous report from a contactable nurse. A 17-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced headache on an unspecified date with outcome of not recovered. The reporter seriousness for headache was medically significant. Information about the Lot/batch number has been requested.; Sender's Comments: Based on the known product safety profile, a causal association between the reported event 'headache' and the suspect product BNT162B2 cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.

Immediately after administration of vaccine, patient fainted. Patient assisted in to wheelchair and wheeled to private observation area. Patient assisted to gurney. Patient has cool compress to forehead. Patient also nauseous, pale, and sweaty. Patient mother reports patient did not eat today. Given water and apple juice. Patient declined granola bar. Vital signs as follows: 0950-BP 88/59, P 86, RR 20, 95% RA, no pain. 0955-BP 92/60, P 69, 99% RA. 1000-BP 96/67, P 75, 100% RA. Education given to patient and mother regarding eating/drinking before next dose and to tell the vaccinator that patient passed out at last vaccine and to lay on gurney before second dose is given. Patient and mother acknowledged understanding. Patient back to baseline at 1010.

Within a couple of minutes of receiving the shot, my daughter felt hotness running down the length of her vaccinated arm and into her hand. Started feeling hot and started to produce a small patch of hives on the outside of the throat and chest. Did vigorous windmill motions with vaccinated arm. She had a feeling of slight unwellness that was followed by a rush of energy. As we leave the store and start to drive home her hives are a little bit worse and she says she feels a little lightheaded and has some heart palpations. But is still reporting a rush of energy. By the time we get home 10 minutes later hives, lightheadedness, and heart palpations have resolved. She feels great the rest of the day. Next day slight redness around the injection site and arm a bit sore. The following day redness is gone but a slight rash is starting to show up around the neck. 5 days later, the rash becomes inflamed, sore, hot and itchy, hives are full upper-body flareups. She takes Allegra 24 for hives control. Rash comes and goes daily. Acts more like hives. Allegra 24 controls hives mostly along with icing. After a few days, the effectiveness of the Allegra 24 is not as efficient with the neck rash. Switches to Zyrtec 24 which seems to provide better relief from both hives and rash around the neck. Sees Dr. April 29th. He advises not to take a second dose of Pfizer at this time and prescribes her an EpiPen.

fatigue; Fever; chills; aches in muscles; This is a spontaneous report from a contactable consumer (Parent). This is the 2nd of 2 reports, for the 2nd dose. A 17-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, at age of 17 years old, administered in Arm Left on 09Apr2021 09:00 (Lot Number: EP6955) at single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included depression. Concomitant medication(s) in two weeks included escitalopram, fexofenadine hydrochloride (ALLEGRA), bifidobacterium bifidum, bifidobacterium lactis, lactobacillus acidophilus, lactobacillus brevis, lactobacillus bulgaricus, lactobacillus casei, lactobacillus paracasei, lactobacillus plantarum, lactobacillus rhamnosus, lactobacillus salivarius (PROBIOTIC 10), all taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EP6955) at age of 17 years old in Arm Left on 19Mar2021 09:00 for covid-19 immunisation and experienced Fatigue, chills and achy, zofran [ondansetron] and experienced hypersensitivity. The patient experienced Fever, chills, aches in muscles, fatigue on 09Apr2021 10:00. Tylenol received for events. And outcome of event was recovered on unknown date. The patient was not diagnosed with COVID-19 prior to vaccination, and Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No follow-up attempts possible. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021335679 same patient and vaccine, different AE and dose

Woke up at 6:30 AM on May 2 with chills and moderate-severe headache, took 2 Ibuprofen at 7:00 AM. Took nap and then stood to speak to my mother, followed by a severe headache for a few seconds and then a seizure lasting less than 1 minute. Hospital released and recommended follow up with PCP for referral to neurologist. No further events as of May 2nd at 9:15 PM

Patient said she was feeling dizzy, vision was blurry, sweeting. Was able to breath, asked for water which was given to her. She had some rash on the face, provided diphenhydramine liquid 50mg. She was feeling feverish, took tylenol.

Sudden sweatiness, nausea and tunnel vision. Very brief LOC. Immediately better when placed supine. More scarred than anything else. No fall or injury. BP/pulse/O2 saturation all Normal Initial 126/89, 69, 100%. No orthostasis. Classic vasovagal reaction. Resolved.

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Seizure-Medium, Systemic: Vomiting-Mild

? Cough sx x 3 days ? Shortness of Breath ? Headache ? Nasal Congestion -consider use of OTC medications such as DayQuil/NyQuil, Robitussin or Delsym for cough - OTC nasal spray and decongestants may provide temporary relief. If you have hypertension, diabetes, thyroid disease, or are pregnant you should avoid using these products. - A mix of 1/2 honey and 1/2 lemon juice can be used to soothe the throat and help loosen thick mucus in the throat or use warm salt water gargles. Use of hard candy, or throat lozenges for sore throat or cough (sugar free if Diabetic) -Steam inhalation by standing in a hot shower or sitting in the bathroom when hot shower is running helps with nasal discomfort. Vaporizers and humidifiers are not recommended due to the risk of burns, bacterial growth in improperly cleaned equipment, and mold formation in the home -Saline nose drops help loosen secretions. Commercial or homemade may be used (1/4 tsp. salt dissolved in 8 ounces warm water distilled or boiled water, discard solution after 48-72 hours) -Consume extra fluids, maintain a nutritious diet, get adequate rest -Take Tylenol as needed for pain and/or fever.

Fainting; syncope Emergency room visit: low blood pressure, high heart rate, administered a bag of fluids to hydrate High fever, chills and lightheadedness

First 3 days, arm was sore, fever, nausea and day 3, vomiting. Every single day since, off and on throughout the day: fever (99-101.9), nausea, headaches in the front part of the head, clammy feeling and lethargic. Starting 5/1, now been dizzy every day. We are on day 22 since the vaccine and this is still happening.

chest pain and chills 2 days after vaccination. seen in ED 2 days after for chest pain. normal labs and EKG. seen 6 days later in this office for continued chest pain and chills. no previous history of chest pain

White blister rash that started at injection site then spread quickly over back, chest, other arm, legs. Light headedness, and tingling and numbness in lips and face. Was given Benadryl 25mg and 2 Tylenol. The rash and numb feeling persisted for 3-4 hours. Several hours later symptoms were followed with a fever and nausea. These symptoms remedied within 24 hours and she was just tired and sore.

Vomitting (cant keep anything down at all),headache, body ache to the point she was crying some of the time, diarrhea, exhausted No fever so far It started at 3:00 am and it is now 7:30 am and she is finally able to fall asleep.... hopefully she improves throughout the day (still early)

left-side facial drop with left mouth corner; stroke symptoms; transient mild headache; blurry vision; left side of tongue affected; slurring speech; felt confused; drowsy; This is a spontaneous report from a contactable consumer (patient). This 17-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8734), via an unspecified route of administration in the right arm at 17 years old on 30Mar2021 at single dose for COVID-19 immunization. Medical history included acquired brain injury (C-PVL) from pneumococcal strep infection, hypoxic ischemic encephalopathy, premature birth, quadriplegic dyskinetic cerebral palsy. Concomitant medications were none. The patient was not pregnant at time of vaccination. The patient previously received T-Dap vaccine at 10 years old and had prolonged migraine reaction. 12 days after, the patient developed stroke symptoms with transient mild headache, blurry vision, and left-side facial drop with left mouth corner and left side of tongue affected causing slurring speech also felt confused and drowsy which lasted for 8 hours. Events were started on 11Apr2021 at 03:30 PM. Events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient went to ER, they did stroke work-up. No evidence of stroke. The patient received treatment including CT scan, MRI, EKG, labs. The patient had no covid prior vaccination, no covid tested post vaccination. Outcome of the events was recovering.

03May21-daughter C/O obstruction in throat. upon view, left tonsil is enlarged, red, 'puffy', striated with white patches. Uncomfortable to swallow. slight runny nose, congested voice, puffy eyelids (slight). Went to urgent care, was tested for Mononucleosis and results positive.

Pt experienced full vaso vagal reaction post COVID vaccine. Cold packs were administered to back of neck and forehead. Pt sweating resolved and color came back. Aided pt to stand until feeling came back in legs/feet. Called Dad into room. He stated he was a nurse and understood the situation. Everyone was calm. Had pt stay for additional time and offered snack once feeling better. Pt was not thirsty so allowed sip on water and gave reese cup. Dad walked around store for a bit before getting into the car.

Site: Pain at Injection Site-Mild, Systemic: Chills-Severe, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Fever-Medium, Systemic: Headache-Severe, Systemic: Unable to Sleep-Mild, Additional Details: mom called to report adverse reaction to 2nd dose of pfizer vaccine. pt had chills on monday, fever on tuesday, wed morning child passed out in the kitchen mom heard her fall, she did call 911. child was transported via ambulance to strong ER. pt was diagnosied with syncope. pt is now home with mild headache/lethargy and recovering. mom has called pcp waiting to talk to her.

Severe headache developed on evening of vaccine. The next morning, patient developed an itchy bumpy raised red rash on her Right forearm while at school. Benadryl helped a little. A worsening headache, cough and wheeze started evening 4/27/21. She took Tylenol and used her Albuterol inhaler. She slept poorly due to itch, headache, bad cough & wheezing. On 4/29/21, 4 hrs after taking Benadryl, she developed an urticarial rash on her Left forearm (right arm improved by then). A pruritic, extensive petechial Left-sided facial rash began that evening which worsened the next am and spread to right side of face. Headache comes and goes. Rash spread to upper arms 5/3/21 despite daily Claritin. Facial rash is fading

Fever; Cough; Fatigue; Congestion; Body aches; Nausea; Shortness of Breath; Acetaminophen (TYLENOL) tablet 650 mg Ondansetron ODT (ZOFRAN-ODT) disintegrating tablet 4 mg.

Patient arrived to post vaccine area after receiving second dose of Pfizer COVID 19 vaccine. Patient reported to post vaccine nurse feeling lightheaded with tongue tingling, headache, nausea and feeling flushed/itchy. Initial vital signs 123/83 85bpm 99% O2. At 1730 patient given 25mg PO Benadryl per standing orders. Patient monitored by post vaccine nurse. Symptoms resolved at 6:15pm, and requested to leave. Last vitals: 117/78 HR 90 O2 99%. Patient had arrived with mother and agreed not to drive. Instructed to call 911/emergency services if symptoms return/worsen.

At 1130 pt reported feeling anxious. OxSat 94%, HR 55, BP 94/58, sweaty, clammy, At1142 Spoke to father, informed him of reaction and treatment. Parent verbalized understanding. @1157 BP 110/68, HR 65, OxSat 98%

Client was lightheaded post vaccine--breathing was not in distress. Client was diaphoretic and pale. Raised clients legs , propped her head up and applied ice packs to her neck. Client recovered in 10 minutes. No 911 call or meds received. Client walked out of clinic feeling "normal".

Date and time of vaccination: (list both if they received both shots): 1st dose 4/6/2021 at 1100. 2nd dose 4/27/2021 at 1100. Date and time adverse event started: ~4/8/2021 (2 days post-vaccination), time unknown. Pt's mother reports that a couple hour post 1st dose vaccination, pt vomited right after. Couple days after 1st dose, pt had a breakthrough symptoms of hallucinations and delusions. Approx. a week later these symptoms gotten better and pt seems to return back to her normal self. Pt reports several hours post 2nd dose, pt vomited off and on and developed chills. In addition, pt's breakthrough symptoms appeared once again but seems worse than from the 1st dose. Today, pt is getting better but symptoms appears to lessen. ***NOTE*** Recommend pt's mom to see MD per these are not a common ADEs of the vaccine. Pt's mom advised pt have a follow up with MD on 5/4/2021. 5/5-Pfizer lot#EP7533, #ER8730. Patient no longer has symptoms, diminished on 5/3/21. No treatment was used to alleviate symptoms. Provider wrote a script for Ativan PRN yesterday but patient has not taking medication as of yet, has used non-pharmalogical coping skills to help alleviate symptoms.

Approximately 15 min after the vaccine the patient c/o headache.pt history and vitals obtained. pt initially refused tylenol but did take 500mg tylenol 5 min later.pt monitored the rest of the time.pt stated she was feeling better and was released with advice to seek further medical attention if needed.

Within a minute of administration, patient became diaphoretic, pale, vomited. Chair reclined. After vomiting, she immediately felt better. She was given water and monitored for 30 minutes. Upon assessment, it appeared as though patient was having a significant amount of anxiety at the time of injection, possibly causing aforementioned events.

While sitting in vaccination chair, patient immediately started c/o of dizziness, and hearing sounding muffled, diaphoretic and hot. Alert and oriented with BP 110/88 P52 and O2 99% on room air. Cold water given with gatorade insert. Cold compress also placed on patient. After 5 minutes, patient stated she "felt better." Alert and oriented x3. Left with mother. No acute distress noted.

The day after vaccine patient developed fever, myalgias, sore throat. Fever persisted 4-5 days. She developed rash on 4/30. Labs done showed low platelets (64k), low WBC with neutropenia. Fever resolved by 4/30 and rash resolved by 5/1/21. Platelets and WBC are recovering.

Patient felt tired, light headache and developed rash at lower right abdomen. Given Benadryl and monitored 30 minutes. Itching stopped but continue to feel tired.

Patient received Pfizer Covid vaccine dose #1 at 4:07pm, 10 minutes later patient said that she was not feeling well. She felt her left arm was going numb, light headed, dizziness and chills. at 4:10 BP was 127/81 pulse 70. At 4:25 bp was 136/82 pulse 83. She was still feeling light headed, cold, and shaking. Pt given orange juice. At this point patient stated she has a hx of losing hearing and then a feeling of passing out. This has occurred more than one time. Pt also stated having lost feeling in both legs with no explanation as to why. 4:35pm bp 133/82 pulse 85, she was feeling cold and shaky. 4:42 pm patient stated she was getting colder and was still light headed. 4:56pm very cold, chills and dizziness. Pt was given another blanket. Both pt and father were asked if emergency services should be called. 5pm per parent;'s request were ok to give 480mg of tylenol, she was very dizzy and cold bp 132/85 pulse 89. Father approved of us calling for emergency services. Pt symptoms not improving. Emergency services arrived pt was able to get onto her feet and walk to the stretcher. Pt stated she is still very dizzy.

pt had headache, fatigue, and severe neck pain one day after receiving 2nd covid vaccine. Was seen in ER on 05/06/21 . was seen in peds office 05/10/21 for follow up.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild

Dizziness, followed by brief syncope, all resolved within 2 minutes. She fell out of chair on to ground and immediately woke. Sweaty and pale, placed cool compress on back of neck and gave her a cold water to drink. She remained upright on the floor for approximately 5 minutes until she felt like she was fully recovered. Her father was present the entire time. She stated that she had no injuries or pain from falling out of chair. No rashes, bruising or bleeding observed. Mgr came over and patient's father declined to file a report for injury.

When I first got the shot I had some soreness and some pain from mid upper are down to elbow. The next day I could be rly wake up, my arm was incredibly sore and I felt sick to my stomach in waves. (rolling nausea) During the day I had off and on headaches that became a full on migraine my dinner. My arm stayed sore and hard to use all day and at night about 7:30 - 8:00 a sharp pain started lancing through my thigh to my knee, after a half hour or so it moved to include down to my ankle, then spaced out between the three randomly till about nine wen it moved to my side for about twenty minutes or so before becoming a dull throb in my leg till I fell asleep. The next day I felt a slight ickyness that last off and on all day as well as a light headache that got worse in the evening. The soreness in my arm dulled down and was just about gone by night, as well as rolling nausea all day though light. Today I woke up a little icky, very tired, and with a headache that has lasted all day and worened during the night, the soreness in my arm is gone.

Throwing up, headaches, abdomen pain, soar throat, chills, fever, sleepy, coughing violently, sneezing constantly, mucus coming up well coughing, wheezing, painful coughs, 05/06/2021

one week after covid #2 vaccine developed fevers, neck pain, headaches and vomiting, treated for lymphadenitis with oral antibiotics with continued fevers now x 9 days

Had temperature of 101.8 degrees F at 8 PM. Gave Tylenol 650mg. Two hours later, temperature was 99.7 and I gave Motrin 400mg. Temperature was 97.7 by the next morning at 07:10 AM.

5 days ago her daughter had a runny nose and cough; 5 days ago her daughter had a runny nose and cough; This is a spontaneous report from a contactable consumer (mother) received from Pfizer-sponsored program. A 17-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. on Apr2021, the patient experienced 5 days ago her daughter had a runny nose and cough. Her daughter got the 1st dose 06Apr2021 and the 2nd dose schedule supposed to be on 27Apr2021, but they rescheduled the 2nd dose on 01May2021 because 5 days ago her daughter had a runny nose and cough. The action taken in response to the events for bnt162b2 was not applicable. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

had pain at injection site; fatigue; This is a spontaneous report from a non contactable consumer. This consumer (sister of patients mother) reported for a 17-year-old female patient. A 17-year-old female patient received second dose of bnt162b2 (BNT162B2, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, The patient had pain at injection site and fatigue. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

While in observation, patient reports being lightheaded and hot. Patient became diaphoretic and pale. Mother and patient state she does this after every injection. Ice pack, cold water, and snack provided. Pt feet propped on chair. Pt. waited additional 15 minutes and states she was feeling better and ready to go. ER/UC precautions given.

immediately felt tingling in her arm. About 3 hours later, she started having side effects. As of this report, it has been 28 hours since she received the 2nd dose. Her side effects are at their worse right now. They include: injection site pain, severe lymph node pain in her armpit, feeling unwell, nausea, low grade fever under 101 degrees, muscle pain in arms and legs, chills and sweats, some joint pain. dizziness and weakness and labored breathing.

Immediate sever pain at injection site, immediately followed by flushed face, racing heartbeat, tingling and inching of face, watering eyes, itchy throat that felt like it was closing in, lump in throat, difficulty breathing, unable to speak. Was able to speak after a couple minutes and the other symptoms started to gradually improve at that point. Most of the above symptoms subsided within around forty minutes. The lump in the throat remained for weeks eventually coming and going.

Per parent report: Friday 4-30-21. Vaccine was given at 1500, at 1730 client displayed a rash on face and chest with extreme fatigue and chills. client took Benadryl. Saturday 5-1-21. Rash gone, but extreme fatigue, crushing pain on chest and pain in arm. continued to take Benadryl. Sunday 5-2-21. Extreme fatigue. continued to take Benadryl. Monday 5-3-21. Still extremely fatigue, DC'd Benadryl. Tuesday 5-4-21. some improvement in fatigue, but experienced some brain fog. Wednesday 5-5-21. attended school where she presented to the health office with medical concerns, see quote taken from an email with the school nurse: "She missed school on Monday and Tuesday due to the reaction. On Wednesday, she presented to the health office with extreme redness to the face and chest. Emergency services was called and she was transported to the hospital. Benadryl was given in the rig to which she responded to well." parent reported that ER doctor ran many tests but did not determine cause. Tuesday 5-11-21. saw Primary Care provider. client is still having significant "brain fog". she is very confused more than half the day, not remembering things or events, and will zone out or fall asleep in inappropriate places with out realizing it.

lIght headed, tingling of fingers, pale, diaphoretic, c/o tingling of the throat briefly. sips of gatorade. hypotensive: 80/40, 88; placed on stretcher semi-trendelenberg . BP: 120/P, No LOC.

hives along both arms and chest one hour after receiving injection. Sensation of throat swelling and very slight difficulty breathing. Did not seek medical attention. Took benadryl and symptoms resolved within 40 minutes of taking benadryl

Headaches, dizziness, fatigue, injection site pain starting approximately 10 hrs after injection and lasting an additional 24 hours

About 24 hours after shot: Nauseous, body ache, head ache About 42 hours after shot: head ache, stomach ache No treatment course taken

Pfizer-BioNTech COVID-19 Vaccine EUA 101.9 F fever, severe right arm pain, not being able to move any part of body without my right shoulder hurting. Nausea, and mild fever for 24 hrs

fever and headache since second pfizer COVID vaccine that was given on 5/1/2021, noted at urgent care appt on 5/10/2021

Patient was sitting in observation for about 10 minutes and complained of feeling dizzy and fuzzy. Pt was pale and sweating. This RN assisted patient to wheelchair and escorted patient to EMS room. Pt was lying on the cot; ice pack was applied to Pt forehead and neck. BP 102/60, P 80. Pt refused drink and snacks when RN offered. Pt reported of feeling better after 15 minutes. Patient's mother was with Pt at all times. Pt and her mother left at 15:30 without any complications.

Patient presented for second dose vaccination. Patient reported seeking medical attention for adverse effects. Patient sought medical attention due to swollen lymph nodes on neck (superficial cervical) and flu-like symptoms (fever, body aches, fatigue, nausea) following first dose vaccination. Lymph nodes prompted CT scan when checked at medical facility. Patient was not admitted as inpatient, no antibiotics were prescriber following encounter but anti-nausea medication was prescribed.

faint; Fever; chills; body ache; diahhrhea; nausea; light headed ness; unable to move cause in so much pain- arms felt like lead weights; unable to move cause in so much pain- arms felt like lead weights; ring in ears; lethargic; This is a spontaneous report from a contactable consumer (patient). A 17-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm on 29Apr2021 13:00 (at the age of 17-year-old) (Batch/Lot Number: EW0172) as 2ND DOSE, SINGLE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. Medical history included seasonal allergies and known allergies to non-steroidal inflammatory drugs (NSAIDs), tree nuts, and pitted fruit. Concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY) and mometasone furoate (ASMANEX). Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, batch/lot number: EW0150), administered in left arm on 08Apr2021 at 01:00 PM for COVID-19 immunization and experienced foggy head and sore arm which was treated with Tylenol. On 29Apr2021 at 23:30, the patient experienced fever, chills, body ache, diarrhea, nausea, light headedness/faint, unable to move cause in so much pain- arms felt like lead weights, ring in ears, and lethargic. Therapeutic measures were taken as a result of all events. On an unspecified date, the patient recovered from all events.

Woke up sore with a mild fever with chills, slightly nauseous and improved as the day went on, mostly back to normal by the day after.

Patient received first COVID19 Pfizer vaccine on 4/18. At that time, had about 3 days of cough and chest tightness. Subsequently began having neck pain on 5/8 and received second Pfizer vaccine on 5/9. Then began having fevers (Tmax 103F), cough. Admitted to Hospital on 5/15 with respiratory failure and shock. Unclear etiology of pneumonia vs multisystem inflammatory syndrome in children (MIS-C). Did not initially respond to antibiotics so treatment for MIS-C was initiated. Now slowly improving but still hospitalized.

THE PATIENT, AFTER RECEIVING ONE DOSE OF VACCINE, PASSED OUT AND WAS HAVING DIFFICULTY BREATHING, SHORTNESS OF BREATH, SWEATING. SHE WAS CONSCIOUS AT THE TIME THE EMS ARRIVED.

PATIENT PASSED OUT IN DAD'S ARMS, CAME TO WHEN WE LAID HER DOWN SWEATINESS AND DIZZINESS RESOLVED ON ITS OWN

Fever - 24hrs Fatigue - 24hrs Vomiting - once around 7:00 PM on May 16 Headache - about 9 hours starting at 1 on May 16

Diffuse hives and erythematous rash on arms, neck and chest. She had expected fever and muscle aches for 24 hours after vaccine administration but this resolved.

The patient received her vaccine at 12:06pm. At around 12:40-12:45 she came back to the pharmacy complaining of her throat feeling strange. She was talking fine with no physical symptoms other than that complaint. She was given 2 teaspoonfuls of Benadryl and was monitored for 30 minutes. At her time of departure she said she was feeling better and was okay to go home. Her mom bought more Benadryl prior to leaving.

Tested positive for Covid19 on 18Apr2021, with symptoms starting on 16Apr2021, after receiving her first dose of the Covid Vaccine on 07Apr2021; Cough; Runny nose; This is a spontaneous report from a Pfizer sponsored program. A contactable Nurse reported for her 17-year-old daughter (patient). A 17-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0150; Expiration Date: 31Jul2021), dose 1 via an unspecified route of administration, administered in left arm on 07Apr2021 at 09:50 (at the age of 17 years) as 1st dose, single for COVID-19 immunisation. The patient had no medical and familial history. The patient did not take any concomitant medications. The patient had no history of all previous immunization with the Pfizer vaccine considered as suspect. The patient had no other additional vaccines administered on same date of the Pfizer suspect. Patient had no prior vaccinations within 4 weeks. On 16Apr2021, evening, the patient started with a slight cough and runny nose and thought it was allergies. The reporter stated that the patient's friend tested positive on Thursday and they were also tested Thursday and she was negative and then Sunday, she tested again and was positive. On 18Apr2021, the patient was tested positive for Covid 19 and was clear now. The patient recovered from her symptoms by 23Apr2021 but she was isolated for the full 10 days. The reporter asked whether it was okay to take second dose after testing positive for COVID-19. The patient did not receive any treatment other than rest. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 18Apr2021 and negative on unspecified date in 2021. The outcome of the event Covid-19 was unknown, and outcome of the event cough and runny nose was recovered on 23Apr2021. No follow-up attempts are needed. No further information is expected.

Fainting/syncope; high fever; lightheadedness; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 29Apr2021 at 14:30 (at the age of 17 years old) (Lot Number: EW0171, unknown expiration) as 2nd dose, single for COVID-19 immunization. Medical history reported as none. No known allergies. The patient's concomitant medications were not reported. The patient also received first dose of BNT162B2 on 08Apr2021 at 16:30 in the left arm (at the age of 16 years old; Lot number: EW0150, unknown expiration) for COVID-19 immunization. The patient experienced fainting/syncope, high fever, and lightheadedness on 30Apr2021 at 06:45 AM. The events resulted in emergency room/department or urgent care visit. The patient received IV fluids as treatment for the events. No COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient is recovering from the events. Information on lot/batch number was available. Additional information has been requested.

Patient was waiting in the waiting area for 6 minutes after getting the pfizer covid vaccine when she started to feel like she was going to faint. Her mom was with her. Her mom had already given her a snack when I was notified. Pt stated her vision was blurry and her hearing was "like she was in a tunnel". She was feeling cold and was feeling scared of that feeling. I asked if I could apply a cold pack and asked her to rest the back of her head against the wall and to close her eyes. I applied the cold pack to her forehead and observed her. She started to sweat and was calmer. She was feeling better and her hearing and vision was back to normal. I had her wait for a total of 30 minutes and had my technician stay with her at that time. She was feeling better and I asked her mom to hang on to her while walking to their car. I followed up with the patient 4 hours later and she was doing well. She said she was feeling well and her arm was not even sore just some fatigue.

About 5 minutes after shot, the patient's mother alerted us to her daughter being unconscious. She was sitting in a chair slumped forward, we pushed her back in the chair. The patient was tensed up, sweaty, with labored breathing. She was assessed to not to be in respiratory distress and held so she wouldn't slide out of the chair she was sitting in. She began to return to consciousness and pulse seemed relatively normal with breathing returning to normal after 3 minutes. Local EMS was activated. The patient was given cold water to hold on her neck and was alert. Local EMS assessed she was ok and the patient's mother refused transport to the ED. The patient left on her own.

2nd dose Pfizer vaccine administered patient was in Observation Area and c/o of sweating and dizziness. Patient fainted for about 2 seconds. Patient arousable and VS were within normal ranges, blood sugar was 68 when being cared for by EMS. Pt states she has had this history of reaction before to vaccines. She had not eaten or drank anything since around 8pm the night before. Patient given water and a food and stated she felt better. Patient remined in Obs area for an additional 40 minutes with EMT, RN and Physician oversight.

Patient began to feel faint within 2 minutes after receiving vaccine. Became pale and diaphoretic. Patient was brought to floor and began to show improvement immediately. Patient remained in observation until 9:05 AM (25 minutes after vaccine administration) and was cleared to discharge home with father at that time.

patient experience dizziness after receiving immunization and later fainted . Patient sat on ground before completely fainting to floor with help of mother and regained consciousness about 1 minute later. patient complained of muffled voices and trouble hearing for about 4 minutes, sweating , dizziness and shakiness. patient received water and Gatorade and cool cloth behind neck area. patient able to leave after approximately 20minutes in care of mother feeling better.

17 year old patient with no known allergies who was given 1st dose of Pfizer vaccine at 1655. At 1700 during observation patient mentioned to the mother that she was not feeling well, was slumped over. The RN on observation noticed that she was apneic, whole body was rigid. Vital signs at 1701: BP 153/88, HR: 64. Oxygen saturation 99%. After 5 minutes a recheck of the vital signs: BP 115/74, HR: 64. Oxygen 97%. Patient did state that she gets anxious when she gets shots.The paramedics were called. Vital signs on arrival: 117/83, HR: 58, Oxygen saturation 100%. Blood sugar 70. After a few minutes patient stated that she was feeling a little better. Patient was able to walk to the ambulance for them to perform an EKG: Results were normal sinus bradycardia.(Patient is an athlete). Patient's mother declined further treated and signed AMA form.

Client received 1st COVID vaccine of Pfizer (Lot# EW0185 expiration 05/23/2021). At 1347, RN assisted Client to stand up from vaccination chair. Client began to have unsteady gate. Both RN and RN assisted Client back to the gravity chair. At 1348, RN and PHN responded to the event. At 1348, vital signs are blood pressure 116/72, heart rate 64, oxygen saturation 100%. Client reported no blurry vision no headache, appearance is pale. Client is accompanied by mother. Per client's mother, Client has no medical history, allergies to dogs, and a history of syncope and lightheaded with needles/vaccines. At 1352, vital signs are blood pressure 118/82, heart rate 62, oxygen saturation 100%. Client reports lightheaded, feels tired, no shortness of breath, no headache. Supplemental nutrition and fluids provided to Client . Client accepted. At 1357, vital signs are blood pressure 116/76, heart rate 63, oxygen saturation 100%. Client reports no headache, no blurred vision, lightheaded improving, feels "sleepy", and skin tone returning to appropriate ethnicity. PHN educated client and mother ED precautions, common adverse effects of COVID vaccine, and emphasize a follow up with primary care provider. At 1400, vital signs are blood pressure 118/72, heart rate 63, oxygen saturation 100%. At 1402 Client stood up with no complains. At 1403 Client walked out of vaccination facility with a steady gait accompanied by mother.

Fever; chills; severe arm pain; nausea; This is a spontaneous report from a contactable consumer (patient). A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8736 and expiration date was not reported), via an unspecified route of administration in right arm, on 11May2021 at 19:15 (at the age of 17 years old) as second dose, single for COVID-19 immunization at a pharmacy or drug store. Medical history was reported as none. The patient had no known allergies. Concomitant medications included sertraline hydrochloride (ZOLOFT), loratadine (CLARITIN) and birth control (unspecified). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0170 and expiration date was not reported), via an unspecified route of administration in right arm, on 17Apr2021 at 13:00 (at the age of 17 years old) as first dose, single for COVID-19 immunization. The patient was not pregnant and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was never tested for COVID-19. The patient experienced fever, chills, severe arm pain and nausea on 12May2021 at 05:00. No treatment was given to the patient for these events. The outcome of these events was recovering at the time of report. No follow up attempts are needed. No further information is expected.

Passed out; Vasovagal reaction; Dizzy; Skin was sweaty; Pale; This is a spontaneous report from contactable Pharmacist. A 17-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Left on 06May2021 10:15 am (Lot Number: EW0171) at the age of 17-year-old as single dose for covid-19 immunisation. Medical history reported as none. No known allergies. The patient was not pregnant. The patient's concomitant medications were not reported. Vaccine was given, patient was sitting with her mother. Approximately 10 minutes after vaccine, she slumped to the side and passed out. When the reporter got to her she was just waking up. She still felt dizzy, skin was sweaty and pale. Paramedics arrived within 5-10 minutes to evaluate. They said they had seen this vasovagal reaction with the covid vaccine. Patient left on gurney with the paramedics. Adverse events start date was 06May2021. Events resulted in Emergency room/department or urgent care. The outcome of the events was unknown. The patient had no covid prior vaccination, no Covid tested post vaccination.; Sender's Comments: Based on a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event of Loss of consciousness. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Pt c/o feeling dizzy, muffled hearing & sweating. Pt escorted to observation and placed on cot in supine position. Pt's VS obtained by clinical staff and (EMS) called. EMS assessed and monitored pt. VS WNL. Medical incident duration from onset to medically cleared by EMS was 7 minutes. Pt reports "I am feeling much better." Pt cleared by EMS that it was safe to go home and driven by her mother.

Shot given 11:58am. Within 2 minutes symptoms began with feeling symptoms: nauseous, hot forehead. I asked CVS for the nurse to help. By 12:01 patient was feeling extreme pain in her stomach, was sweating profusely, felt tingling sensation from head down to her stomach (including her arms and hands). Patient began screaming in pain. Her hands became rigid and paralyzed. She was completely unable to move both hands. Patient was able to feel if someone was touching her hands. Her face began tingling and feeling numb. Patient was lying down and almost passed our. I asked CVS to call 911 and if they should administer an epi pen. The epi pen was not administered. I (mother) went w/ child in the ambulance to Hospital. EMT monitored her vitals, which were normal. Patient was still unable to move her hands until after she was admitted to Hospital. Patient did not receive any IV r medication at Hospital. The sensation in her hands slowly came back with the numbness subsiding after about 1.5 hours in the ER. Patient was discharged at about 2:00pm on 5/16/2021.

customer states she took her second shot of the vaccine and she has been having eye inches and running noise and not feeling well. Called her and she is ok.

Patient was given dose at a vaccination site through County Health Department. Today in clinic she reported an allergic reaction to Pfizer vaccine. Approximately 30 minutes following vaccination had hives. Following morning had swollen lips and itchy throat with continued hives. Symptoms only treated with benadryl and improved. She then had hives again 4 days later. She did not report this to the vaccination clinic.

Initially developed hives then swelling of lips, face and difficulty breathing with cough (anaphylaxis reaction). Treated by school nurse with epipen then ambulance paramedics arrived and administered nebulizer treatment, IM benedryl, dexamethasone and transported to ER for follow up stabilization. ER administered additional antihistamine. Patient was discharged from ER stable and in much improved condition.

(Vasovagal Response) Felt tired and ?felt like fainting? immediately after shot. Pt laid down and elevated feet. No additional treatment needed. (Initial BP 87/58)

Tachycardia began at 27 hours after vaccine with hear rate up to the 160s . Fever developed after the tachycardia 31 hours after vaccine. Patient was monitored in the hospital on propranolol and was sent home on propranolol.

After receiving dose, pt experienced Vasovagal response which she never had before when receiving a shot. When they woke her she had a lot of jerky arm movement. About half an hour to 1hr after injection she said she had an odd taste in her mouth and her tongue was numb. Her chest felt tight but was not wheezing. About an hour later when she was home (~6pm) gave her "click it albuterol" and it relieved the tightness in the chest. She had pain in her left breast area. Around 6:30pm she continued to comment about her tongue being numb and pain in her breasts. She fell asleep right away and the next afternoon around 1pm she had a temperature of 99F. After motrin the temperature went back to normal and she felt better. No further chest tightness after that and she is feeling normal.

Systemic: Chills-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Medium, Additional Details: patient was feeling cold, hot, shaky, weak, a heavy chest feeling, numbness in extremities a few minutes after her vaccine. Her pulse went from 80, 99, to 110 after 3 readings. Her BP was normal. Her brother said she just had a unspecified chest procedure. It wans't noted on her intake. She wasn't feeling after lying down for 30 minutes with legs propped up and wanted to paramedics to come. They sent her home after another 30 min. She doing well before she left.She went to school day after.

Patient became light headed and fainted from a seated position about 10 minutes after her first Pfizer COVID-19 vaccination. She doesn't think she lost consciousness. Her skin was quite warm and sweaty after this event. I had her remain laying down on the ground while she recovered and I assessed her symptoms. She felt better almost immediately so I had her move to the pharmacy office for observation for an additional 15-20 minutes. She then reported that she has fainted with shots before and she hadn't eaten anything today. Her mother said this has happened before and drove her home once she felt well again.

Patient was extremely nervous prior to vaccine. Got shot, walked out of room to waiting area. about 2-3 minutes post vaccine, realized did not feel well. Passed out. Mom said patient felt a touch rigid and twitched a couple times, then came too. Did hit head when patient fell to floor, although was not a major hit. Patient was worked up after coming to.

Pt was swimming and started to cough (felt swallowed water) and upon getting out of water - collapsed and lost consciousness for a few seconds

Fever of 103; chills; sweating; body ache; nausea; vomiting; diarrhea; headache; couch; chest pain; This is a spontaneous report from a contactable consumer for herself. A 17-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 07May2021 17:00 (Lot Number: EW0176) at single dose for COVID-19 immunisation. Medical history was none. No allergies to medications, food, or other products. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant at the time of vaccination. The patient previously received first dose of BNT162B2 (lot number=EW0153) in left arm on 15Apr2021 04:00 PM for COVID-19 immunisation. The patient experienced fever of 103, chills, sweating, body aches, nausea, vomiting, diarrhea, headache, couch, chest pain on 08May2021 13:00 with outcome of not recovered. Events were resulted in doctor or other healthcare professional office/clinic visit. No treatment received. Patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19.

Pt felt lightheaded and sweaty and heart rate dropped to 50 and blood pressure dropped to 70/30. Paramedics were called 911 and arrived at 12:32 the episode happened at 12:30 by the time the paramedics arrived she was feeling better she had been put on the floor with her legs elevated on a chair and her blood pressure has come up since then she had refused to go to the hospital because she fell back to her normal.

Pt diaphoretic, pale, nauseas, blurred vision, difficulty hearing, lightheaded, SOB, 10 minutes after receiving pfizer. Given water, vital signs obtained. HR low into the 50s, O2 sat 93-94%. Placed on a stretcher. After vitals obtained pt color returned and she stated she started feeling better. HR improved to 70s, O2 sat 97% on RA. BP stable throughout.

On 5/19 she got her first Covid Vacc (Pfizer). The following day she had mild fatigue and chills, but it did not interfere with activity. Then 5/21 PM she noted a discomfort in her chest. By yesterday she had marked chills, felt burning hot, c/o a mild ST and mild nausea and abd pain. Her chest discomfort (poorly characterized in location) worsened and she was brought to ER with concerns that she had another effusion. At the hospital, she had 24 hours of fever and hypotension.

Multisystem Inflammatory Response to the vaccine with fever for 5 days, elevated LFT's, low Na, low platelets, elevated CPK. Patient hospitalized for 2 days.

Less than 1 minute after received the shot, patient became clammy and pale while sitting in chair. Her eyes rolled back in her head and her body went slack. Myself (parent) and the nurse who had given the shot braced her on either side while she appeared to fade in and out of consciousness for several minutes (she seemed to occasionally interact with us, mumbling responses to 'yes' or 'no' questions). The nurse did not want to lower her to the floor, but wanted to keep her propped on the chair. Her head kept rolling to the side. At one point, she began to jerk rhythmically. Just as I was about to bring this to the attention of the nurse, the patient returned to consciousness. Patient was moved to a rolling recliner chair and taken to a recovery area where I (parent) did not see her for another 30 minutes as I was receiving my own shot. The chair she had sat in was wet, but it was assumed this was due to sweat (patient had sweated profusely). On the way out of the clinic, noticing a wet stain on the back side of patient's pants, I asked if she had wet her pants (quietly) two separate times. Patient denied it both times. However, upon returning home, patient confirmed that she had wet her pants. Patient was monitored during the evening for similar adverse events ; none noted. Patient ate lunch approximately 1 hour before receiving shot and was given crackers while at clinic. Patient is a well-hydrated individual, and also drank water while on-site. No fever either before or after shot. A slightly elevated BP the next day (135/83). However, patient complained of headache, fatigue, and pain at injection location; elevated BP may be related to headache and/or ordeal from day of the shot.

1-20 minute bouts where tics appear "seizure-like," repetitive; many persistent involuntary tics including coprolalia and violent motor tics; had one minor chronic tic before vaccination/many persistent involuntary tics including coprolalia and violent motor tics/Noticed increase in severity and frequency; many persistent involuntary tics including coprolalia and violent motor tics; Tics often include hitting oneself and banging head against things/violent; significant distress; persistent headache; chronic fatigue/sleepiness; lightheadedness; decrease in appetite; feeling of pressure in certain locations inside the head; intermittent earaches in both ears; persistent feeling of brain being "on fire," and "like a parasite has invaded the brain."; chronic fatigue/sleepiness; This is a spontaneous report from a contactable consumer (patient). A 17-year-old female non-pregnant patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration, administered in Arm Right on 26Mar2021 as first single dose and on 16Apr2021 as second single dose (Batch/Lot number was not reported) for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Other. Medical history included asthma, allergy to nuts, penicillin and ongoing chronic tic. No other vaccines within 4 weeks prior to the COVID vaccine. No covid prior vaccination. Concomitant medications included duloxetine; atomoxetine; hydroxyzine; loratadine. The patient previously took amoxicillin and experienced allergies. The patient experienced neurological symptoms included many persistent involuntary tics including coprolalia and violent motor tics. Smaller tics can be suppressed for minimal amounts of time before uncontrolled, violent/loud tics occur in rapid succession. Tics often include hitting oneself and banging head against things. The patient had one minor chronic tic before vaccination. Initial onset occurred nine days after vaccination from 04Apr2021. Noticed increase in severity and frequency approximately nine days after second dose of Pfizer vaccine. Symptoms cause significant distress. Additional symptoms included: persistent headache (from date of first vaccine to present); chronic fatigue/sleepiness; light-headedness; decrease in appetite; feeling of pressure in certain locations inside the head not related to the skull or skin; intermittent earaches in both ears; persistent feeling of brain being "on fire" and "like a parasite had invaded the brain, start date was 26Mar2021; and "1- 20 minute bouts where tics appear "seizure-like," repetitive, violent, and controlling". The patient underwent lab tests and procedures which included Spit test: negative (other) on 26Mar2021 and Apr2021, Covid test: negative on 26Mar2021 and on Apr2021. The events resulted in: Doctor or other healthcare professional office/clinic visit. No treatment received; the patient was not recovered. Information on lot/batch number has been request.

Site: Pain at Injection Site-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Fever-Medium, Systemic: JAW AND THROAT PAIN-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium

Site: Pain at Injection Site-Medium, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: BP 103/65 Pulse 62-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Mild, Systemic: Shakiness-Mild, Additional Details: EMS was called but she went home with her mother and slept the rest of the day, she had a sore arm on Tuesday but was otherwise fine per mom.

Patient began to sweat, complained of blurred vision, and turned very pale in the face. We called 911 and I stayed with the patient monitoring heart rate and symptoms. Patient was slightly tachycardic upon initial assessment. Once EMS arrived, patient had had resolution of blurred vision and the sweating. Her vitals were normal. Her mom refused further treatment to the hospital. I recommended to follow up with pediatrician.

Patient upon seated for the 15 minutes post-vaccination fainted. When she was coming through, she started shaking as if she was having a seizure. When I reached the patient, she was shaking and then came through and stopped shaking. Patient was still pale, sweating, and didn't feel okay. 911 was already called once the patient was shaking. As I am checking in on the patient, the mom discloses that she has fainted at least twice before and when she comes through she shakes but it is not seizures. However, during the screening process, patient and mom stated the patient never had any problems when getting vaccinated. I got her BP checked and it was 102/61 and HR of 92. We had the patient sit still and drink water. When EMS arrived within 5-10 mins, they took her vitals and it was 112/70s and HR of 84 with 98% O2 sat. Patient and mom decided to be taken to the ED to make sure she is okay.

High fever 1 day after vaccine of 102, SOB since vaccination (unresolved), chest 4 days after vaccination (resolved)

Passed out/ got chills and sweats after receiving vaccine at the Pharmacy. Proceeding the vaccine she had headaches and still gets them and it?s currently 05/27/2021 which it?s been 9 days since also for 3 days after vaccine was extremely exhausted.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Headache-Mild, Systemic: Shakiness-Medium, Systemic: Weakness-Severe, Additional Details: Patient was given Pfizer vaccine, told to remain in waiting area for 15 minutes. Immediately after shot she seemed and and was conversing with me normally. 2-3 minutes later her dad noticed that she was tipping over and called for help. When I rushed over, pt was moved to the floor, close to passing out, very weak and shaky. We called 911 - she was responsive. she laid on the floor until ems arrived at which point they took over and took patient to get further checked out.

Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Medium

She fainted and collapsed about 18 hours after receiving the second dose (6:30 am). She was confused for about an hour after she fainted. She was on ibuprofen (400 mg taken at 5:30 am). Other than weakness, headache, and fever, she has had no other adverse reactions so far besides the single fainting episode.

Site: Pain at Injection Site-Mild, Systemic: mentrual changes-Mild, Additional Details: headaches, no appetite, stomach ache, light sensitivity, fatigue, mentrual cycle distrupted. Patient states she got her period 2 weeks early. She takes an oral contraceptive pill, she did not miss any

Within 2-3 minutes she felt sick and dizzy, then became clammy and unresponsive. She was moved to the floor and regained consciousness within 1 minute. Was given water and a snack and felt better. She left happy and healthy, she does not like needles/vaccination - so she had anxiety from the vaccine.

FELT DIZZY AND HAD A WITNESSED SYNCOPAL EPISODE, TRANSPORTED TO COT, APPEARED DIAPHORETIC AND PALE. PARAMEDIC CAME, BP 86/51, HR 49, OFFERED HYDRATION, SX RESOLVED, NO TRANSPORT, AMA SIGNED.

Follow up report - The symptoms - severe headaches; shortness of breath; difficulty breathing; chest pain and throat pain with activities - even if he walked across the room he had this pain along with the shortness of breath; body aches and fatigue. He is an athlete and not able to do any of the sports - he starts breathing heavily when he walks across the room. He couldn't attend school for over a month. Has been to several physicians - a pulmonologist several times; cardiologist; gastroenterologist; his pediatrician. He got a steroid shot - 24th, given to him for the headaches. Last Monday, the 24th of May (the pulmonologist gave this to him). It (the headaches pain) was really bad on Tuesday, Wed, Thursday and he started feeling better with the headaches on Friday. He has been given an inhaler and Pepcid for acid reflux (gastroenterologist). These have given him a little relief - but he don't know if it's the steroid shot or the inhaler that is helping. Yesterday he tried to go to his Sports class and he couldn't do it - there was a problem with breathing; a lot of shortness of breath. The headaches and the breathing issues are still what are debilitating him the most.

Roughly 2 minutes after receiving her I am Pfizer vaccine, patient told mother that she was feeling slightly lightheaded. She proceeded to lose consciousness. Mother honk the horn and alerted staff to come to help. Patient was in the car on the passenger side, patient was fully sitting up. I reclined her all the way down in her passenger seat, she was slightly gasping for air, Ambulance was called for evaluation. She had loss of consciousness for approximately 30 seconds. She regained consciousness and said she was feeling confused as to what it happened. Denies any feelings of needing to vomit, Or post ictal symptoms. EMS and fire we?re on scene by then, report given to paramedics on site. Patient declined further medical treatment and Ian made with the ambulance. after this stating she was a little tired. She continue to wait for 30 minutes, she had 1 episode of emesis and felt better. At the site with no issues.

Patient reports muscle aches and significant fatigue for 3 weeks following the second vaccination. Initially just with sore arm, then a few day later developed the fatigue

2 hrs after vaccine started having chills and fever by Thursday April 22 her legs starting hurting pain moved from toes and all the way up to back then it stated moving to her hands and fingers. got admitted to hospital because they wanted to make sure she wasn't having syptoms of MS they did blood work, MRI, covid test, xrays, lupus test, physical therapy, nerves test, lime disease test and everything came back fine by sunday they sent her home and she started having stomach pains and had to go back to Dr. she has experience hair loss and it started her menstrual cycle early. was having alot of fatigue and its's been a month and she is now finally started to feel a little better but Dr dont know how long it will be before she is fully herself

First on Saturday May 22 had sore arm, then pain that thought was possibly heartburn/indigestion, fever over 100. Took acetaminophen and tried Tums. Then on Sunday May 23 chest pain that didn't feel quite like indigestion and fever over 100. Continued acetaminophen and Tums. Monday May 24 felt like heart was fast, hot flash type feeling like could faint and some light headedness/off feeling, continued chest pain. Pediatrician prescribed omeprazole to see if helped, did EKG. Checked in on Wed May 26, no change except no fever and light headedness improving. Referred to cardiology.

Sneezing a lot, after the first and second vaccine; Right arm with rising and swelling: described as red in a crescent moon shape at injection area, after first vaccine; red in a crescent moon shape at injection area, after first vaccine; Vaccine poured and trickled out of arm, after first vaccine; Vaccine poured and trickled out of arm, after first vaccine; This is a spontaneous report from a contactable consumer. A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 21Apr2021 (caller states it was the evening) (Batch/Lot Number: EW0161) as 1st dose, single for covid-19 immunisation (Reported as because she is her daughter's mother, and told her daughter to get the vaccine. her daughter's school is making all the seniors get the shot to go back to school). Medical history included Birth control. Family Medical History relevant to AE was No. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (LOESTRIN FE) from Mar2021 (two months ago) taken for birth control. Prior Vaccinations (within 4 weeks), no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. AEs following prior vaccinations was None. Caller states she is calling for her daughter. Caller confirms she is calling about the Pfizer vaccine, confirmed as the Covid 19 vaccine. Caller states that when her daughter went and got the injection, some of the vaccine poured out of her arm, vaccine poured and trickled out of arm, after first vaccine was on 21Apr2021 3:20 pm. Caller states that 3 days later (in the morning), her daughter's arm started to get a rising, later clarified as swelling. Caller states that it was red, in a crescent moon shape, and raised up off her arm at the injection site. Caller states it was really huge. Caller states that she called the pharmacy and she was told to give her daughter Benadryl and Cortisone cream. Caller reports that this treatment was effective. caller then reports that her daughter had lasting effects, clarified as sneezing a lot, after the first injection and then it got more intense after the second injection. The event was not required a visit to Emergency Room and Physician Office. Relevant Tests was None. No Investigation Assessment. Treatment received for the events. Outcome of red in a crescent moon shape at injection area, after first vaccine was recovered on 26Apr2021 (also reported the area is still a little brown spot but not raised up off her arm). Outcome of Sneezing a lot was not recovered. Outcome of the events was unknown. Seriousness criteria is Medically Significant. Information on Lot/Batch number was available. Additional information has been requested.

After receiving the shot she experienced the "Covid's bullseye", a circle on her arm at the site of administration; tired; her arm was a little sore; the girl got a rash of the diameter of a lemon on her inner thigh, next day on both legs; This is a spontaneous report from a non-contactable consumer (patient grandmother). A 17-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 20May2021 (age at the time of vaccination 17-year-old) as 2nd dose, single for covid-19 immunisation. Medical history included allergic to sulfa drugs. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as 1st dose, single for covid-19 immunisation. The patient concomitant medications were not reported. It was reported that after receiving the shot patient experienced after receiving the shot she experienced the "covids bullseye", a circle on her arm at the site of administration, tired, her arm was a little sore. On Saturday, the patient got a rash of the diameter of a lemon on her inner thigh, so the reporter told her to only use sunblock, next day (Sunday) both legs were covered in a rash. Reporter looked on the Pfizer's website and saw that rash was reported in 0.001 percent of people who had the vaccine. Also, on Sunday, reporter took the patient to the doctor but he was not there, so she called a service (reporter did not elaborate on this) and a person told them that the rash could be from a serious disease called "petechiae rash" and told them to take patient to ER where she got the shot. Once in the ER, they told them that it was not the serious condition "petechiae rash" but that it was a "rash" and that they had never heard before of anybody experiencing a "rash" after the administration of the vaccine. Reporter wanted to know if "rash" has been reported as an adverse event of the Pfizer's COVID-19 vaccine, how long after the administration of the vaccine appears and how long it lasts. She would also like to know if we can call the facility to let them know that "rash" was reported as a side effect of the vaccine, since she was upset because she does not understand how someone in the ER does not know that "rash" was an adverse reaction and they had them thinking for a couple of hours that patient could be suffering of a serious disease. Reporter does not want someone else to go through this situation. Reporter mentioned that in the ER told them to wait 2 days and give Benadryl to patient, so she wanted to confirm if this was the right treatment for patient and if she should wait those 2 days to see if the rash was gone before she calls the doctor. Reporter wanted to know how long after the administration of the vaccine the rash appears and how long the rash would last. The outcome of the event was unknown No follow-up attempts are possible. No further information is expected.

Fever; Joint pain; facial and tongue swelling/broken out in a rash broken out in a rash that moved to her face and lips/anaphylaxis/daughter's eye started to swell; Serum sickness; elevated CRP; Hives/an allergic reaction/lip and face swelling; This is a spontaneous report from a contactable consumer (the mother) reported for her daughter. A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular, administered in left arm on 02Apr2021 10:00 (Batch/Lot Number: EN6207) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included Colitis ulcerative from 2014 and ongoing, Genetic immune deficiency, additional Information for other conditions: Caller describes it as "22q". patient was born with this but wasn't actually diagnosed until patient was 11 years old. They checked with patient's Immunologist before getting the vaccine especially with her daughter's history. Thyroid disease from 2015 to an unknown date, additional Information for other conditions: patient didn't have a thyroid- her thyroid was removed. Concomitant medications included cetirizine; famotidine; montelukast sodium (SINGULAIR); and epinephrine (EPIPEN) all taken for an unspecified indication, start and stop date were not reported; aloe vera, pramocaine hydrochloride (ATARAX ANTI ITCH LOTION) taken for itching, swelling and hives, start and stop date were not reported. The patient took first dose of Pfizer COVID vaccine on 12Mar2021 10:00 (Lot: EN6207) for COVID-19 immunization and patient had no side effects after the first dose. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). The patient just saw her Immunologist and her Immunologist instructed her to report what is going on with patient. Caller clarifies patient's immunologist plans to call and report as well but also instructed her to call and report the side effects her daughter is experiencing. Her daughter was cleared to have the COVID vaccine. The caller explains they always check with her immunologist because of her daughter's immune issues. Her daughter received the second dose of the COVID vaccine on 02Apr2021. On the evening of 04Apr2021, her daughter broke out in hives. They didn't think it was a big deal, they thought it was just an allergic reaction. She tried Benadryl and several other things. They went and saw her daughters regular general practitioner and the doctor believed it was just a delayed skin reaction, which seems to be common with the Pfizer COVID vaccine. The doctor told her he's seen one other person with this delayed reaction. He gave her daughter a steroid injection, a Steroid Dose Pack and Pepcid. She was also placed on Benadryl as needed. About 2 weeks after this, her daughter and lip and face swelling and ended up in the Emergency Room (ER). At this ER visit, they initiated the allergic reaction protocol and it was not an anaphylactic reaction at that point. Her daughter received IV Benadryl and IV steroids, the caller is not sure what else. She confirms she has no NDC, Lot number and expiry dates for the medication her daughter received in the ER. The ER doctor contacted the Immunologist on call and the Immunologist had seen a few cases with a delayed reaction. Caller clarifies the ER doctor discussed her daughter's delayed skin reaction with the on-call Immunologist. The oncologist put her daughter on generic Zyrtec, 20mg in the morning and 20mg at night. The following week, her daughter woke her up with facial and tongue swelling. She clarifies further her daughter had fever, joint pain, and had broken out in a rash that moved to her face and lips. She immediately took her to the ER. The ER followed the whole anaphylaxis protocol and was given an EpiPen. She explains her daughter was diagnosed serum/covid sickness. This has been going on for over 6 weeks. The reaction will come and go. She was told as her daughter's body develops immunity, she is basically allergic to it. She clarifies at her ER visits, they checked her daughters liver and kidneys. It was noted her daughter had and elevated CRP, which is an inflammatory marker. The caller was told they thought her daughter had serum sickness from the vaccine which may last 4-6 weeks or it may be prolonged, so they just went with it. They told her as long as it didn't move to her lips or affect her daughters breathings, eventually it would wax and wane and go away. Her daughter started breaking out on her arms and legs and last Saturday, she woke up and her face was swelling. She clarifies her daughter's eye started to swell and her tongue. She took her straight to the ER and the ER followed the anaphylaxis protocol and injected her with an EpiPen. They contacted her Immunologist to check and make sure it wasn't anything else and consulted with the Covid Vaccine Clinic and it was found 3 other patients had this happen. No further details were provided regarding the 3 other patients. Right now, her daughter is on 4 different medications and an EpiPen. They contacted her insurance about her being placed on a biologic because not even the current medications her daughter is on is making everything going away. Caller verifies her daughter was never admitted into the hospital. When she was last seen in the ER Monday, she her daughter was monitored for 4 hours after the EpiPen was administered. The events require a visit to Emergency Room (total of three ER visits) and Physician Office. She known the last/third ER visit was Monday, 17May2021. The second ER visit was 04May2021. She believes the initial/first ER visit was probably a week or so before the second one. She clarifies she broke out in hives on 04 Apr2021 and went to the doctor on 07Apr2021 or 08Apr2021 so the ER visit was around the next week. Since her daughter had such a good response from the EpiPen the ER doctor took pictures before and after. She clarifies the name of the biologic they want to put her daughter on is Xolair, it is a monthly injection. She explains the current cocktail they have her daughter on is not working. She provides the following product information for these 4 medications and EpiPen. Relevant Tests included she knows they are testing for any other thing that it could be to rule it out. She knows they ran a CIS-tray, a complete CIQ , a Histamine release something and Tryptase. She knows they checked her CRP (inflammatory marker) because it was elevated. Every time her daughter went to the ER, they did a CBC and all of that was normal except for the CRP inflammatory marker, however her CRP was normal at the last ER visit. The outcome of events was unknown. No follow-up attempts are needed. No further information is expected.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: Patient received 1st dose of pfizer vaccine. Less than 1 minute later patients mother alerted us that the patient had lost consciousness. She was immediately laid down and gained consciousness within 10 seconds. She stated feeling lightheaded, sweaty, looked pale and felt like she was in a trance. 1st BP reading (111/67), 2nd BP reading done 15 min later (106/59 & HR 65). After 30 min of monitoring patient was able to leave.

8 hours post vaccination, developed subjective fever, chills, headache, malaise 6/2: Around 32 hours post vaccination, developed acute chest pain, shortness of breath, difficulty breathing when laying flat. Required ibuprofen. 6/3: felt better, required ibuprofen. Presented to ED on 6/4 with continued symptoms (chest pain, shortness of breath), noted to have elevated troponins. Transferred to Hospital on 6/4 to ICU for monitoring. To the floor on 6/5. Clinically doing well just on NSAIDs with slowly decreasing troponins. Dx: probable acute myocarditis per cardiology based on clinical symptoms and troponin leak

5 mins after administering vaccine pt had difficulty breathing, chills, sweats, blurry vision, nausea, temp was 95, numbness in hands, and ringing ears. Possibly a seizure her mom said her arms were shaking a little I didn?t see anything

Fever ranging from 99.8 to 102 for 54 hours. Fatigue (slept for 15 hours on first day); lower back ache, headache, muscle ache

Patient tolerated administration of vaccine well and was monitored in observation room by two RN's for 15 minutes and patient felt fine to leave. Patient left room and came back shortly after feeling very fatigued, nausea, and pain in both calf's- L leg worse than R , with red toes. Bilateral pedal pulses +2. Vitals: BP 130/67 HR 92 Sat 95% on room air. Gatorade given to sip on. RRT was ultimately called and patient was taken to ED.

Patient had syncopal episode approx 5 minutes after first injection. Patient reports that bystanders said that she had seziure-like convulsions. Pt has no memory of event. Pt complaining of headache.

Systemic: Abdominal Pain-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Hypotension-Severe, Systemic: Nausea-Medium, Systemic: Shakiness-Mild, Systemic: Vomiting-Medium, Systemic: Weakness-Medium, Additional Details: Following 2nd covid-19 vaccination, patient became very lightheaded and fainted while seated in chair. After coming to again, she was very pale, having a hard time controlling her breathing and stated she couldnt see. 911 was called and upon the paramedics arriving, blood pressures both sitting and standing were taken, as well as a blood glucose reading. The patients blood pressure was low but stable, and her blood glucose reading was normal. Patient walked out of store with paramedics and Mom.

patient was nervous/anxious about the shot. Sat in chair and received shot in the left deltoid with no issue. Stood up to leave a minute later and told her mom that she felt dizzy and nauseous. We had her sit back down and she got a little shaky. Face seemed to loose all its color. she said everything went black and she was dizzy. she closed her eyes and laid her head back against the wall. I left the vaccine room to alert my pharmacist and as I walked out the door the patients brother said that she had started shaking like she was having a seizure and she passed out. She was seated and mom was supporting her while we called 911. patient came to within 30 seconds or so and was lethargic and dizzy still. Pharmacist too her blood pressure while waiting on emt and it was 102/52, heart rate 64. emt arrived and took over. emt was with the patient for about 10 minutes then left with her on a stretcher. emt left notes that her vitals while sitting were 93/56, heart rate 66, o2 100%. standing 80/50

After receiving the vaccine we moved to waiting area. Within minutes she told me she was not feeling well she began sweating profusely, her skin became pale and clammy, her eyes rolled back she lost consciousness and began convulsing. She came to and said she could not hear well. She was taken to ED for observation and testing.

Patient told us that she has passed out and vomited after receiving vaccines in the past. After getting the vaccine, she didn't feel well. We monitored her in the vaccine room for about 5 minutes. She had a drink of water, then when she was ready, her family helped her into the lobby I returned to the pharmacy, and continued to watch her. The patient's mom came to the window and said patient had fainted. I went to her, and said we need to lower her to the floor. At that point, mom said patient was not breathing I quickly lowered her to the floor, while dad supported her head. I didn't have time to verify that she wasn't breathing, because as soon as she touched the floor, she began convulsing, then sat up and w was immediately awake. She sat up, and we explained that she had passed out and I had her lie down. I stayed with her for a few minutes, asking if they wanted an ambulance (which mom and dad declined) while making sure she was ok. She was just resting at this point, so I returned to the pharmacy, and ask them to let me know if anything changed I continued to watch her from the pharmacy window, and the patient said she was nauseated. We gave mom a bag, and patient vomited in the bag. After a couple more minutes, she seemed to be recovering, and mom and dad helped her out of the store. I followed up with mom at 4:15pm, and mom said patient was still nauseated and had vomited a couple more times. I followed up one last time at 4:45pm, and patient was feeling a bit better, but mom was going to keep an eye on her I recommended that mom take her to a doctor to be evaluated, but mom said she would just keep an eye on her through the night. I told mom that I would follow up again in the morning.

Swelling on the left hand (fingers) - a ring couldn't be taken off. The injection site was red and very itchy - that lasted for about three days. There was a lot of drowsiness; fatigue; upset stomach - lasted about a week. Went to Primary care doctor; he said it was a side affect. He told us to keep an eye on it. The swelling lasted three or four days.

Irregular Menstrual Period: short cycle (15-22 days), heavier than typical period pre-vaccine, prolonged period (12 days), no treatment given Extreme Fatigue: Sleeping 8-9 hours and can barely function through a typical day, irritable Frequent headaches lasting multiple days

received the first dose of the Pfizer COVID-19 vaccine and also recently started taking Depo-Provera. After receiving the first dose of the Pfizer COVID-19 vaccine her daughter developed a blood clot; tired and frail; feels lost and light headed; cramping pain; This is a spontaneous report from a contactable consumer (Patient's mother). A 17-year-old female patient received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Right on 03May2021 15:00 (Batch/Lot number was not reported) as 1ST DOSE SINGLE for covid-19 immunization and medroxyprogesterone acetate (DEPO-PROVERA), route of administration, start and stop date, batch/lot number and dose were not reported for contraception. The patient's medical history and concomitant medications were not reported. The patient experienced received the first dose of the pfizer covid-19 vaccine and also recently started taking depo-provera. after receiving the first dose of the pfizer covid-19 vaccine her daughter developed a blood clot, tired and frail, feels lost and light headed and had cramping pain all on unspecified dates. It was reported that after receiving the first dose of the Pfizer COVID-19 vaccine her daughter developed a blood clot. Her daughter, who is currently on Depo Provera got her first dose of the Covid 19 vaccine. The daughter has been experiencing blood clotting and would like to further document this experience. Is also seeking medical advice to inform her daughter. Her daughter Has been on Depo Provera for 4 to 5 months. Since she had the Covid vaccine, she has been having bad blood clotting and has been having a continuous period. When she got the shot, she has been getting blood clots straight for three weeks. Patient is Tired and frail: She is a waitress, so all of this has made it hard. It started right when she got the shot and has pretty much stayed the same. She will feel like she is lost when she wakes up and is light headed from the loss of blood. It occurs when she is doing activities, like working. Patient took some Midol one day for cramping pain but it barely did anything. The action taken for medroxyprogesterone acetate was unknown. Outcome of tired and frail was not recovered. Outcome of all the other events was unknown. Information on Lot/Batch number was not available. Additional information has been requested.

Arm hurt; Tired; Rash all over both of her legs; This is a spontaneous report from a contactable consumer (patient's grandparent). A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration in the left arm on 20May2021 16:30 (Batch/Lot number was not reported), at the age of 17-years-old as 2nd dose, single for COVID-19 immunization. Medical history included allergic reaction of Sulphur drugs. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 on an unspecified date for COVID-19 immunization. The patient had her second Pfizer shot on Thursday 20May2021 at 4:30, the only side effect she seem to have, was her arm hurt and she was tired and the reporter don't know, her aunt was a pharmacist and said that circle that she developed at the site of the shot, and called it as a Covid bullseye. On Saturday 22May2021, the patient had rash about the size of a diameter of a lemon on the inside of her leg, the reporter didn't think anything out she has been out in the sun so they just observed until Sunday, 23May2021 she got the rash all over both of her leg. Previously she was has an allergic reaction of Sulphur drugs so with this rash all over both of her legs what they did was they called her doctors office Sunday and they haven't answering. They have a service that you can call about medical things, person that answers, there was a woman and said she know nothing about a rash they thought it would may be side effect from Pfizer because the reporter looked on the website and in the website rash was listed, usually rare. The patient does not have anaphylactic shock any of that there was a rash they think it was 0.001 they tried to explain this to the woman and she insisted it was something called Petechiae rash, which is a serious rash. She insisted not take the patient to the urgent care, she said they should take her to the ER and not urgent care, they took her to the ER they said they didn't know, it was definitely not the Petechiae rash which was a released that's a serious problem. They said it was okay to just give her Benadryl which they could have decided to give at home, but they didn't know if Benadryl was okay to take if the patient took the COVID vaccine. They were advised to bring her back to the doctor in 2 days if it doesn't go away. ER said they had never seen anyone who had a rash, they don't know any rash. The reporter tried to tell that it's on the website it's on a Pfizer website and thought she was thinking she should alert them about this because this was a lot of lot of gut ranching and anxiety that if this person calling from the doctor saying that the rash was a Petechiae rash which was a serious blood disease. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Woke up in morning around 8:00 with nausea and vomiting. Nausea most of the day. Headache, severe lower back pain

Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: PT fainted several minutes after vaccination and fell out of the chair. Pt regained conciousness immediatly after fall but suffered minor injuries to the face and knee (rug burn). She felt nauseous, light headed, dizzy and was pale and had cold clammy skin. She regained her complexion after 15 minutes and rested for 45 minutes before leaving.

Day after vaccination, patient reports intermittent fevers (Tmax 104F), neck pain that radiates down her back, and is interacting a lot less than usual, The following day, she was unable to walk at all and required being carried to use the bathroom. Patient denies and fevers, cough, gi distress. She does states that she is not feeling short of breath at this time, but is having weakness in her hands as well as her legs. Additionally patient states that she has been having chest pain today that comes and goes. On neuro exam Mental status: Appears to be distressed due to photophobia. Lethargy, however easily arousable, able to have a conversation, attention intact to spelling "globe" backwards, intact to high and low frequency words. Able to name and repeat. Speech: Mild dysphonia Cranial Nerves: II: Pupils equal, round reactive III/IV/VI: EOMI. Pupils move in all four cardinal directions VII: Face symmetric when talking, however limited effort to excursion on command VIII: Responds to voice IX/X: Voice normal XI: Turns head side-to-side XII: Tongue midline Motor: Normal bulk and tone. Resistance met to passive motion of BLE RUE/LUE: shoulder abduction 4/5, elbow flexion/extension 5/5, wrist flexion/extension with give-way weakness up to 4+/5, finger flexor 4/4 RLE/LLE: On command, 0/5 -however able to support her legs in a flexed position bilaterally, with encouragement 5/5 on dorsiflexion. Able to support her weight on her legs, however does not walk slowly sits back on the bed. Sensory: Intact to light touch, proprioception intact Coordination: No obvious dysmetria on FNF testing DTR: 2+ brachioradialis, bicep, patellar, ankle b/l. Plantars mute. Absent pathological reflexes: Hoffman, cross adductor

Client Received the 2nd dose of Pfizer COVID vaccine lot #ER8735 and expiration date 07/04/21 at 1:34pm. At 1:34pm, client reports to vaccinator that she feels dizzy. Vaccinator offer client water and client starts drinking it. PHN 1 & PHN 2 arrive client reports she "feels weird" PHN asks client to explain and client is unable to describe. Client is alert and oriented X 4 and is already seated in zero gravity chair due to reporting history of syncope. Vaccinator offered client water and client starts drinking it. Client reports no headache, no shortness of breath, no blurred vision, no chest pain, just dizziness. At 1:34PM vitals heart rate taken manually by PHN :72 and blood pressure: 128/74, unable to get oxygenation due to long acrylic nails. PHN gets report from mother that client reports with the first dose something similar happened that she experienced dizziness after vaccine. Client was kept in observation and symptoms resolved prior to client going home. Clients mother reports no medical history, no medications and no history of allergies. At 1:36PM PHN gets called away for another adverse reaction and PHN stays with client. At 1:39pm client reports dizziness is resolving but still "feels weird", PHN asks client to clarify what weird means and she says "it feels like my heart is slower." At 1:40pm client reports she is feeling sleepy, PHN attempts to call 911 and gets disconnected. At 1:41pm vitals: blood pressure: 130/82 and pulse:134. At 1:42pm PHN calls 911 again to reconnect and observes clients lips look purple, closed eyes but able to answer questions and speak in complete sentences. Ask RN to get AED as instructed by 911 dispatcher. At 1:45pm, client reports having trouble breathing and RN placed zero gravity chair to laying position and assist client with coaching her to take slow deep breaths. Fire department paramedics arrived at 1:47pm and assumed care. Client was wheeled out on a gurney at 1:50pm.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: PT fainted and fell out of the chair several minutes after administration of vaccine. Pt regained conciousness immediately after fall. Suffered minor injuries to the face and knee (rug burn) and felt dizzy, lightheaded, and nauseas for at least 15 minutes before regaining complexion. PT discloses after incident that she has issues fainting with blood draw and some injections. PT rested for 45 minutes in the store before leaving. Vitals reviewed are normal before leaving the store

17 y/o F with a hx of asthma and GBS presents to the ED for weakness and difficulty moving beginning on 6/7/2021. Pt got her second COVID-19 vaccination on 6/6/2021 and has had an intermittent fever since (Tmax 104 F). Pt has been taking Motrin and Tylenol; last dose was at 07:00 today. Note, pt only had a fever after the first COVID-19 vaccination. Mother reports pt's baseline includes normal range of motion. However, in 2016 pt was diagnosed with GBS and was hospitalized for temporary paralysis for 1 month. Pt was also diagnosed with mononucleosis in 2017. Mother reports pt has also had neck pain that radiates down her back, and is interacting a lot less than usual. Pt denies any confusion, but admits to a mild headache. Differential Diagnosis: Guillain-Barre Syndrome, status post vaccine, tick paralysis, thyrotoxicosis, consider meningitis and other infectious causes like UTI, URI. Patient admitted to hospital.

Pt reported that she felt dizzy and sleepy and endorsing weakness after covid vaccine. Pt was sent to the emergency department. Pt felt better after eating and was able to ambulate with no dizziness or weakness. Pt stated she "feels better" and left.

This was my daughters second shot. She experienced 90 minutes of uncontrollable shaking around midnight with whole body. Also, with headache and overall body aches and hot and cold spells.

Systemic: Chills-Mild, Systemic: patient reported some dizziness and tingling and anxiety. Patient had a pulse of 125 and temp 98.4 Called emergency services and continued observing patient till they arrived; symptoms lasted 0 days

Achy joints, soreness throughout the body, a splitting headache that started this morning when the joint pain lessened. Feverish but unsure if I actually have a fever at this time.

100.1 fever at 630pm , swelling of face, chest pain , trouble with breathing , redness of face , and body pain at 8pm ,

Immediately after vaccination patient reported feeling lightheaded, diaphoretic. Witnessed syncopal episode in bay (no head trauma), assisted to recliner by vaccinator. BP 90/80 at start of event. Given Gatorade and crackers with minimal effect. 15 minutes after treatment BP 80/70 and administered O2 via nasal canula. Transported via wheelchair at 12:06pm.

Fever; chills; headache; joint pain; This is a spontaneous report from a contactable nurse(patient). A 18-year-old female patient received first dose BNT162B2, intramuscular at Arm Left on 11Jan2021 14:00 at the 18 years old at single dose for COVID-19 immunization. The medical history and concomitant medications were not reported. On 11Jan2021 17:00 the patient experienced Fever, chills, headache and joint pain.There was no treatment received for the adverse events. The patient had no covid prior vaccination. There was no covid tested post vaccination. The outcome of the events was Not recovered. Information about Lot/Batch has been requested.

a headache started; I felt sick with fatigue, chills and muscle aches.; muscle aches began; cold chills began; my temperature was slightly elevated for me but still not a fever at 99.1°/99.7°/went up to 100°/100.5°/ 100.2°/99.8° but still elevated; I was really fatigued; my energy levels weren't 100%; This is a spontaneous report from a contactable consumer (patient). An 18-year-old female patient (not pregnant) received the first dose of bnt162b2 Lot Number: EL8982, via an unspecified route of administration on 16Jan2021 12:15 at single dose at Left Arm for COVID-19 immunisation. Facility type vaccine was other. Medical history included Congenital Partial Aortic Bicuspid Valve, Aortic Dialation, Postural Orthostatic Tachycardia Syndrome, no known allergies. The patient didn't have covid prior vaccination. The patient's concomitant medications were not reported. There were no other vaccines in four weeks and no other medications in two weeks. Patient stated when she woke up, her temperature was slightly elevated for her but still not a fever at 99.1°. At 1:00 pm, she was really fatigued with her temp still at 99.1°, at 2:30 pm, cold chills began and her temp was 99.7°, at 2:45 pm, her temp went up to 100° & muscle aches began, at 4:00 pm, her temperature was 100.5° and she felt sick with fatigue, chills and muscle aches. At 5:45 pm, a headache started and at 7:30 pm, it got horrible and her temp was 100.2°. At 10:15 pm, her temp went down to 99.8° but still elevated and she was very fatigued. The next day, Jan18, the fever was gone and she woke up with a 98.2° temp which was consistent throughout the day but she had a persistent headache most of the day and her energy levels weren't 100%. She didn't take any medications any of these days. Adverse events started from 17Jan2021, 01:00 PM. No treatment was received for the events. The patient had recovered from the events. COVID was not tested post vaccination.

4 February 2021@0300-patint says she had body aches, Threw up, fever HA and SOB @ this time 1000-4 February 2021-she feels poopy/crappy I reminded her to go to the ER if she gets worse Motrin doesn't really help her feel better-she can sip some Gatorade to assist with the HA, BA & fever

The day of the vaccine, my arm started to hurt, and the day after, I felt sore all over, and felt like I had a fever. Have been feeling very lethargic and have a headache as well.

felt sharp pain behind right ear which lasted 2 hours; headache; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). An 18-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318, expiry date: unknown), via an unspecified route of administration in the left arm, on 24Jan2021 13:00, at single dose, for COVID-19 immunization, at the workplace clinic. Medical history included depression. The patient was not pregnant at the time of vaccination. The patient has no known allergies. Concomitant medication included an unspecified birth control pill, melatonin and multivitamins. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686, expiry date: unknown), via an unspecified route of administration in the left arm, on 03Jan2021 12:00, for COVID-19 immunization. The patient did not receive any other vaccine in four weeks. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. On 24Jan2021 17:00, 4 hours after vaccination, the patient felt sharp pain behind right ear which lasted 2 hours. On 24Jan2021 15:00, a few hours after vaccination, the patient started having a headache which, as the patient reported, "hasn't gone away, even with a Tylenol, actually feels worse than when it started on Sunday". Treatment for the events included Tylenol, heat, and quiet and dark room. The outcome of the event "felt sharp pain behind right ear which lasted 2 hours" was recovered on 24Jan2021 at 19:00; and headache was not recovered.

Patient received second dose of Pfizer vaccine on 2/5. Patient was anxious during administration of vaccine. Discussed how patient felt after first dose vaccine and SE experienced (sore arm only - tolerated well). After she calmed down, then administered vaccine when pt felt ready. ~10/15 min later patient reported flushing, trouble catching breath, pulsing headache & shaky. Gave 2 Benadryl, monitored BP/HR (normal), injection site (normal), no angioedema/blocking of oral cavity/throat. Patient advised to lay down and reported feeling better ~ 1 hour later.

Throwing up; vomited 4 times; Chills; Headache; Fever; highest temperature was 101.4 degrees; low-grade temperature; Nausea; Stomach was not feeling right; upset stomach; This is a spontaneous report from a contactable consumer (patient's mother who is a caregiver). An 18-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), intramuscular in right arm, on 26Jan2021 at 07:30, at a single dose, for COVID-19 immunization. The patient's medical history included birth control pill. The patient's concomitant medication included ethinylestradiol/ norgestrel (CRYSELLE) from 26Jan2021 as birth control pill. The patient previously took the first dose of BNT162B2 on 05Jan2021 at 08:00 AM for COVID-19 immunization (in right arm). The vaccine was administered in a hospital facility. The patient was a certified nursing assistant (CNA) at a hospital. The patient and her mother both work at the same hospital that administered their COVID-19 vaccines, both received the first and second COVID-19 vaccines at the same date and time. The patient received her second COVID-19 vaccine dose yesterday (26Jan2021). Since 26Jan2021 around 09:00 PM, the patient was experiencing symptoms of chills, headache, fever, and nausea. The patient had a fever, clarifying that the highest temperature was 101.4 degrees, and also has chills and headache. Last night (26Jan2021 at 09:00 PM), the patient's stomach was not feeling right, had a low-grade temperature, and chills. On this morning (27Jan2021), the patient was throwing up. The patient didn't throw up until this morning and has vomited 4 times today. The patient has not sought medical treatment from an emergency room or doctor yet. The patient has been throwing up today. If the patient continues throwing up, and becomes dehydrated, she may need to go the emergency room. It was also reported that the patient started ethinylestradiol/ norgestrel last night. The patient's mother thought that the patient's initial stomach upset may have been caused by the ethinylestradiol/ norgestrel. Therapeutic measures were taken as a result of headache and fever including ibuprofen and acetaminophen; the patient isn't taking anything for nausea at this time. The patient's mother wanted to see if anyone else had been reporting these side effects the patient has been experiencing since receiving her second COVID-19 vaccine dose. The patient had not recovered from the events. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.

Pt came up to the EMS table and stated she did not feel well. Pt lost conciousness from a standing position and was caught and lowered to the ground. Pt was unconcious for approx 5 minutes. Pt regained conciousness. Pt was placed in a wheelchair and wheeled to the examination room. Pt was monitored for 30 minutes. Pt states she is feeling better and would like to leave. Pt was walked out to her car. Pt was driven home by her mother. Pt did not require transport.

Pfizer-BioNTech COVID-19 Vaccine EUA Headache, lasted around 2 days. Sore throat and post-nasal drip, 2 days fever cough

After receiving first mRNA COVID vaccine, patient experienced flushing, headache, chest tightness, shortness of breath, and nausea. Patient was initially monitored in an observation area, given crackers and juice. After 35 minutes she was transferred to the ED. IV line was placed, labs drawn, and given acetaminophen and ketorolac, fluids and ondansetron. Patient was later discharged after remaining stable.

Asthma; Syncope; Dizziness; Nausea; Vomiting; Severe headache; Fever; Muscle weakness; Muscle twitching; Fatigue; Chest tightness; This is a spontaneous report from a contactable consumer (patient). A 18-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no: Em9810), on right arm via an unspecified route of administration on 23Feb2021 10:30 at single dose for covid-19 immunisation. The patient medical history was not reported. There was no known allergy. Concomitant medication included sertraline, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). Historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Feb2021 04:45PM on Arm Left for covid-19 immunisation. On 23Feb2021 10:30 patient experienced syncope (medically significant), dizziness, nausea, vomiting, severe headache, fever, muscle weakness, muscle twitching, fatigue, chest tightness, asthma. No treatment was received for the event. Patient not having COVID prior vaccination. Patient not tested COVID post vaccination. Outcome of the events was recovering.; Sender's Comments: Based on the strong temporal association, the association between the event syncope and the vaccine BNT162b2 administration cannot be completely ruled. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Fever developed the day after the vaccine and has lasted for 5 days. ( ongoing fever currently )Temp ranging between 101-102.7. Chills and body sweats. No other symptoms.

Began with heavy feeling in limbs, progressed to painful joints and muscle weakness. Extreme fatigue, headache, and fever and chills throughout the day 3/7. Woke up feeling better on 3/8.

fever of 101.7 degrees, chills, aches, fatigue, nausea. have been happening since last night and have continued into today

Low grade fever for 2 days after first shot (101) Rash beginning 8 days after shot, swollen and red but not painful at the vaccine site

-pain in right side of entire body, -entire face rash- rash on face- could be from epiduo forte which is used 2x/week for the last 2 months ? -chills

Immediately following vaccination, patient "saw black", became diaphoretic and pale. Patient was laid on floor with feet up on chair. Vitals: 1600 BP 87/52 HR 52 98% (laying 1602 102/68, 57, 98% (laying) 1604 103/74, 66, 100% (laying) 1605 111/69 73 100% (sitting on floor) 1609 106/69, 64, 100% (sitting in chair) Pt was eating, talking and drinking water. Symptoms resolved. No further treatment needed.

patient became diaphoretic and light headed. Patient was anxious and did not eat breakfast before vaccine. Patient was instructed to lay in the floor and she did so with no difficulty and did not pass out. BP and pulse taken all within normal limits and juice and fruit snacks given and consumed with no difficulty

6:45AM- blurred vision and chills upon getting out of bed followed by loss of consciousness for ~30 seconds. Vomiting upon regaining consciousness. Fever of 38.5C. Took Tylenol, drank water, and slept from 7AM-8AM. At 8AM, chills and blurred vision had resolved. Was able to eat, drink, and take medication without further vomiting. Fever persists. New mild headache starting around 8AM.

Red itchy, hives, and swelling forearms on left and right side starting just before 4 hours after vaccination. Slight sore throat pain about 4 and a half hours after and last about a half hour. Took two benadryl, feel better now. :)

Starting on 28th of march on Headache Muscle aches especially at injection site Injection site is hot Tiredness Overall unwell feeling

migraine at rhe base of my Head; My heart rate rose to around 133 just laying down; extremely nauseous; inability to control temperature regulation; stomach began to have a really intense stabbing pains; Not the worst pain I have experienced but definitely not pleasent; lethargic; getting extremely cold and then hot within a matter of minutes; Her ribs and lungs hurt; Her ribs and lungs hurt; This is a spontaneous report from a contactable consumer (patient). An 18-year-old female patient received second dose bnt162b2 (Pfizer COVID 19 vaccine), via an unspecified route of administration, administered in Arm Left on 24Feb2021 10:15 (Lot Number: EN6202) as single dose for COVID-19 immunisation. Medical history included known allergies to Red dye, postural orthostatic tachycardia syndrome (POTS), heart murmur, Wilkies syndrome. The patient was not pregnant. There were no concomitant medications. The patient did not take other medications in two weeks. The patient previously took Excedrin and experienced allergies. The patient previously received first dose bnt162b2 (Pfizer COVID 19 vaccine), via an unspecified route of administration, administered in Arm Left on 03Feb2021 09:45 AM (Lot Number: EL9269) for COVID-19 immunisation. The patient did not receive other vaccine in four weeks. On 24Feb2021 at around 7:00pm she started getting a migraine at the base of her head. She then was lethargic, and became extremely nauseous. She started getting extremely cold and then hot within a matter of minutes (inability to control temperature regulation). Her heart rate rose to around 133 just laying down. Her ribs and lungs hurt. And her stomach began to have a really intense stabbing pains. At one point it felt as if she could feel every cell in her body if that makes sense. Not the worst pain she had experienced but definitely not pleasant. On a scale of 1 to 10 (10 being run over by a car and 1 being a paper cut) she would say it was a 5-6. The patient did not receive treatment for the events. Facility type vaccine was facility. The patient did not have COVID prior vaccination and did not have COVID test post vaccination. The outcome of the events was recovered on an unspecified date.

On Friday 3-19 she had a swollen lip. It went down and she had her first dose of COVID vaccine. Saturday she was well and had a fever on Sunday. Fever went away and she felt better until Tuesday when she had a high fever on Tuesday night. Wednesday she had swollen puffy eyes but they were never red in her conjunctivae. Thursday seen by Dr. Labs showed mild increase in LFTs and Cr. She had lymphocytosis and atypical lymphs consistent with a viral infection. She was negatvie for EBV and had a negative COVID swab. She does not have history of exposure to COVID a month ago. She is careful at school. They are tested frequently and no one has been sick, however one of her roommates had mono. Friday and Saturday fevers continued. Saturday repeat labs showed higher LFTs and negative CMV. ESR and CRP and ferritin are elevated. She has no rashes, cough or congestion. She is mentally clear and not light headed. She has a headache when her fever is high but otherwise is okay. No conjunctivitis, No sores in mouth or lips, and no swollen LNs.

My daughter had intense sweating and felt like she was going to pass out. This started a few minutes after receiving the vaccine. The reaction after the shot only lasted for roughly 5 minutes, but her clothing was completely soaked from sweat. After 5 minutes, it passed and she felt much better. Medical personnel gave her water and had her sit another 30 minutes. She seemed fine after that, but they told to report the reaction.

Red slightly itchy rash on elbows, inside of mouth felt swollen and irritated, sore throat, arm slightly sore where the shot was given

PT STATED NOT FEELING WELL AND SHE SAID SHE IS NOT ABLE TO SEE. PT FELT DIZZY AND FAINTED. SHE FELT BETTER AFTER ELEVATING FEET AND WAITED 30 MIN FOR OBERVATION.

Eight days after her injection, Raised bump that looked like two mosquito bites about the size of two nickels pushed next to each other; brief 99-101 F fever that lasted only an hour or two for two consecutive nights. Bump turned flat and area got to be more of a red spot in similar size. Resolved itself in 24 hours after redness. Not serious but worth mentioning because I have read about this fairly uncommon side effect from recent NEJM article, but ghe article stated the effects were coming from folks who had the Moderna shot, and not the Pfizer.

Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Mild, Systemic: Shakiness-Mild, Additional Details: Patient fell out of chair #7 in pharmacy. This author caught patient and brought to floor. EMS called at 12:44. Nurse on site took patients BP 108/66. Could not get HR. EMS arrived at 12:52. EMS evaluated patient. Gave patient cold water. Patient declined hospital transfer. Patient was over 18 and EMS gave her paper that stated she declined hospital care. EMS left 12:57.

client received covid vaccine approx 5-10 min later c/o feeling sick to stomach and light headed. client vomited moderate amount of brown liquid. client was pale and clammy. client was checked by ems.

17 y/o female, 5 minutes post vaccination c/o lightheaded ness, pt. Fainted for <15secs, upon assessment pt is pale, cold, clammy. Paramedics V/S taken, HR 72, BP 107/75 (sitting), standing HR 92, BP 80/50, NS bolus was given and pt still c/o lightheaded ness, dizziness, nausea. Taken to Hospital for further evaluation. Taken by Paramedics.

Had a headache that quickly turned in to the chills and a fever of 103. This lasted for about 4 hours and then she started to feel better. Within 5 hours of the symptoms starting she felt completely better.

The patient reports experiencing blurred vision, vertigo, throbbing unilateral headache upon arrival to her seat. The medical team assessed her and found her HR to be 76 bpm, BP 142/80, BG of 72, and her oxygen saturation was 99%. She reported that she had not eaten all day and had not had a lot of water during work. She reported that she typically gets migraine headaches lasting for several hours. She was given some water and her symptoms started to resolve. She asked if she was able to go home.

Fever, 11pm 04/09/2021-10am 04/11/2021 (peaked at 101.5°) Headache 04/10/2021 Left arm pain 04/09/2021/04/11/2021 Nausea 04/09/2021-04/10/2021 Chills 04/10/2021 Treated with tylenol extra strength, took 2 times over the course of 10 hours

expected symptoms started at 24 hours: vague abdominal cramping, nausea, diarrhea, fatigue. and continued for 72 hours, then progressed to chills, sweats, intractable vomiting, severe abdominal pain and severe diarrhea. Visit to clinic required - IV fluids. Technical problem getting laboratory evaluation so return visit tomorrow if still symptomatic. Currently improved, but still with abdominal cramping and diarrhea.

Patient received dose at 11:30am, proceeded to obs area. Within minutes, she experienced c/o nausea, lightheaded feeling, and headache. Denies SOB, chest pain, or pain otherwise in body. Denies feeling of weakness. Patient reports exact symptoms with first dose, lasting all day. 11:45 BP 110/75, pulse 75 steady. Clinically stable, symptoms no worse. Patient mother agreed to transport patient home to recover, plans on calling provider re: mast cell activation and symptom management. Patient transported to personal vehicle via wheelchair without incident. NP

Intense soreness, tiredness immediately after for 3 days Starting on 4/11 loss of taste and smell Starting on 4/12 loss of taste and smell plus sore throat, runny nose and difficulty breathing

Two hrs after 2nd dose of pfizer on April 9, 2021, patient experienced the following for the next 48 hours: pain at injection site and redness; fever or 102; nausea; tiredness; chills (lasted 24 hours); headache; and muscle aches all over. All of this was handled through Sudafed Severe Cold tablets as if she had the flu.

Patient loss consciousness immediately after receiving the vaccine. EMS arrived immediately and the patient regained consciousness. The mother believes that the loss of consciousness may be due to the patient's medications and not the vaccine. Patient stated she felt tired and refused EMS treatment. No further issues.

Itchy throat, sweaty, "feels like under water", tinglng arm where vaccine was given. Juice provided, monitored and released with Mom. Phone call follow up later that day, she was doing well.

Immediately after injection, felt lightheaded, queasy, diaphoretic. BP- 70/34, p-70, repeat BP- 87/55, p-72 given juice, water, and laying down on gurney. After 30 minutes, reports feeling better, repeat BP- 96/60, p-73, O2sat- 98% Able to sit and stand without feeling dizzy or lightheaded. Discharged home with mother and ER precautions

acute sinus infection; bilateral cerumen impaction; Bilateral otitis media; Had a syncopal episode; Dizzy; This is a spontaneous report from a contactable physician. A 18-years-old female non-pregnant patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8730), dose 1 intramuscular, administered in right arm on 24Mar2021 as single dose for covid-19 immunisation. Medical history included dysmenorrhoea, menometrorrhagia, obesity, guillain-barre syndrome. Concomitant medication's included ethinylestradiol, levonorgestrel (LUTERA) taken for an unspecified indication, start and stop date were not reported. The patient previously took fluconazole (known allergies). Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was tested for Covid test post vaccination on 25Mar2021 show the negative result. Patient claimed she became dizzy within 15 minutes of the vaccine and had a syncopal episode. She stated that it occurred twice since the vaccine. This MD conducted physical exam on 30Mar2021 and found bilateral cerumen impaction that was cleared. She reported that this revealed bilateral otitis media and she was diagnosed with acute sinus infection and treated. Although her symptoms can be explained by these findings, this MD was continuing work up for Guillain-Barre. The adverse event result in Emergency room/department or urgent care. Treatment received for the adverse event are supportive care, antibiotic for sinus infection and clearance of impacted cerumen. The outcome of the events were recovered with lasting effects. No follow-up attempts are needed. No further information is expected.; Sender's Comments: The event syncope is assessed as possibly related to the suspect vaccine BNT162B2 based on strong temporal association, but consider also possible contributory effects from patient's medical history and/or concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Right after patient received vaccine, she experienced severe dizziness that she had to sit down. She also had shivering, warmth, nausea and vomiting

Within 5 minutes after being vaccinated patient started feeling really warm with extreme pulsating headache and major tremoring in her hands. These symptoms started to worsen for her as she also started getting facial tics and sensitivity to light, so patient's Mom did take her to the emergency room to be assessed/observed/treated.

immediately after vaccine pt states feeling sweaty, spots in vision, muffled hearing, brought to OBS via wheelchair by reaction nurse. given water and transferred self to stretcher, placed in tredelenburg, vs monitored as noted. pt feeling better once laying down, pt slowly positioned to sitting up to dangle and then to standing. feeling better with position changes pt states normally has lower BP no further symtpoms. ok to discharge home pt ambulated to exit at 0935 vs 0913 bp 97/60 hr 73 rr 18 o2 96, 0919 bp 109/65 hr 77 rr 18 o2 98, 0924 bp 108/76 hr 91, rr 18 o2 97 low fowlers, 0926 bp 98/64 hr 92 rr 18 o2 98 dangle 0932 bp 110/64 hr 86 rr 18 o2 98 0933 bp 111/72 hr 92 rr 20 o2 98 standing

Pt reports day 1 post vaccination fever, throat tightness; diffiuclty swallowing; difficulty breathing "a little"; dizziness; lightheadedness. Pt sent to ER

patient was given her injection where she developed itchiness of her throat, neck, chest, and abdomen. then she began to get lightheaded. 12:31 BP 192/ 86 HR 85 12:38 BP 179/84 HR 99 she then began to develop a raised macular rash on her chest and neck 12:45 patient given 25 mg of po benadryl. 13:00 BP 150/77 hr 87 oxygen sats of 98% room air patient feeling better rash disappeared 13:07 BP 150/82 hr 78 oxygen sat 100 % room air 13:10 patient was released with her mother and she was escorted to the exit with staff

12 hours after receiving the second dose of Pfizer I felt fatigued and my injection site was red and swollen. 24 hours after the vaccine I was experiencing abdominal cramping, headache, and fatigue. 48 hours after I developed a severe full-body rash/hives/welts. It started as a small patch on my left arm and progressed to my hips, legs, arms, chest, back, and face - my whole body. The rash is extremely itchy and has caused me to bust blood vessels from scratching so hard and frequently. I began rotating Benadryl and Zyrtec, but it seemed to make it worse. I visited the ER in the middle of the night on 4/18 where I was given steroids and Benadryl IM along with Pepcid. The rash went away a few hours after, but has since then reappeared and I am currently running a low grade fever of 100.2. I am taking Prednisone 20mg 3x a day as prescribed by my doctor along with Benadryl 50mg every four hours and Pepcid twice a day. Despite these medications the rash continues to persist.

[April 10; Evening]: Headache with small pounding feeling, a slight fever. [April 11, Morning]: Slight pressure on injection sight, weak limbs, vomiting, fatigue. [April 11, Evening]: Unconsciousness, nausea, delirious, fever. [April12-14]: Extreme Migraines, dizziness, loss of balance while walking, unconsciousness, loss of appetite. Took Pedialyte and liquid pain reliever everyday.

Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe

Patient received 1st dose Pfizer 2:15pm (Mother was present) with a minute, patient states that she can't see anything and her body was feeling fatigue. I sat her down, she couldn't talk and answer any questions. I quickly got my tech to call 911, they came quickly and monitored her and took her to the hospital.

Chills: 13 - 37 hours after injection Sweating: 20 - 37 hours after injection Leg muscle pain: 23 - 26 hours after injection Hard itchy red lump appeared below injection site

Pt became nauseous/sweaty/dizzy 10 minutes after 1st vaccine. Passed out w/ EMS for about 20 seconds then vomited. Pt fully recovered and hydrated. Released home.

1328 - Father stated daughter didn't feel well - walked to stretcher and fainted. 1330 - Patient awake, VS taken, on stretcher, color improved, talking. BP = 98/53, HR = 74, RR = 22, O2 Sat = 100% 1335 - Patient sitting up. 1340 - Patient talking, drinking soda. BP = 117/76, HR = 80, RR = 22, O2 Sat = 100% 1350 - Patient's color pink, in no apparent distress. BP = 129/71, Hr = 83, RR = 16, O2 Sat = 98% 1351 - Patient ambulated out of clinic with father.

Patient had continuous coughing start within 10 minutes of dose 2. O2 sat remained normal with clear lung sounds throughout 40 minute observation. Patient coughing did not respond to albuterol inhaler. Patient and her father who was present opted to be transferred to ER via ambulance for further observation.

Event described to me by RN who administered the vaccine, the patient was nervous prior to receiving vaccine and experiences anxiety regularly. After receiving vaccine, patient became increasingly anxious and began sweating. Blood pressure reportedly dropped to 90/70 at which time RN administered an epipen 0.3mg. 911 was subsequently called to further care for the patient.

I did not feel any reactions to the vaccine for 4 days after I got it. However, Sunday night I got a really bad headache and my temperature was slightly higher than normal around 99. Then, all day on Monday I had a very intense fever, I was sweating all day, bad headache, and very fatigued. My fever was around 100.4 Monday afternoon around 2 PM and increased, I felt horrible. My fever peaked around 7-8 pm, it was around 102 degrees. I took 2 fever-reducing tylenol on Monday. I scheduled a rapid PCR COVID test for Tuesday morning. However, today (Tuesday. 4/20) I feel great and I do not have any side effects.

1:50 Called into observation room by RN. for assistance with this patient. Pt had Dose 2 of Phizer at 1: 16 pm and was now complaining of nausea and lightheadedness. Pt asissted to floor, legs elevated up on a chair. Pt is alert .He stated, his name is (unlisted). Skin: pale, hands diaphoretic. Immediately, pt 's chest was pounding;HR was elevated , pt's eyes closed and he appeared attempt to answer this RN's questions as to how he feels, however, could not. Would not/could not open eyes. It appeared that he was shaking/mild jerking as with the chills, however, this RN was discerning if it was seizure like activity. Upper body flushed/red. This lasted about 30-45 seconds. Then pt.'s shakiness slowed down, heart pounding resolved and he opened his eyes. Able to squeeze nurse hand. 1:53 pm DPN Came to assist.Ice pack to forehead Pt was still shaky, but now responding. Still w/ complaints of nausea, lightheadedness. 2:05 still lying on floor with legs elevated. 2:10 Sat up for 5 minutes. C/o nausea. Placed in wheelchair. Within 1 minute, pt. Is pale, shakiness returns, and c/o nausea. Returned to the floor , legs elevated and 9-1-1 initiated. HR steady, respirations -steady. MOC now present.Pt. now responding to MOC or RN's commands to squeeze hand or Speak. Eyes closed. HR and RR steady. 9-11 arrived at 2: 15 pm and pt. Left facility with paramedics and MOC.

18 y/o female while in the recovery area, @ 12:58 c/o feeling very sweaty, diaphonic, initial vitals @ 12:58: 110/82, 63, 20 and sats 99% on room air, no c/o any other signs of distress, monitored, after 5 minutes : @ 1:04 patient stated feeling much better, sweating has passed, repeat vitals @ 1:06 112/75, 60, 20, sats remain 99% on RA, continued to monitor in recovery until 1:21, dc vitals 94/62, 73, 20, sats remained unchanged. DC home w/Mother who accompanied her to the clinic, stable in no further distress.

Within minutes of pt receiving covid vaccine, verbalized to 'not feel well' and fainted. A friend and staff members gently assisted pt to the floor. Immediate assessment of vital signs and pt taken to private area for monitoring. Pt may have had vasovagal response due to anxiety.

Around 1 am (4/20/21) following the second dose (4/19/21), felt body ache symptoms and chills. At 8 am on (4/20/21), had a fever of 101.7 degrees F, a large headache, chills, and body aches. By (4/21/21) the fever, chills, and body aches were gone but the headache remained until the evening of the 21st.

The first time I had the vaccine my throat started burning and chest tightness I stayed with the nurse for a good half hour and I started to feel better so I left by the time I made it to my car I throw up I decided to go home in about an hour later calm down. The second time I had the vaccine 04/21/2021 my throat was burning my chest was tight I had hives I was vomiting and having hot flashes for a good hour at that point my symptoms were not coming down so I was sent by ambulance to the hospital I have to give him Benadryl on a steroid I was at the hospital for a good five hours my symptoms were gone. The next day 04/22/2021 I had some soreness in my arm my body was sore and I was really tired later that night I started feeling really hot and my legs were stinging and burning I looked at my legs and there was a rash and a rash on my face and a rash on the left arm where I had the vaccine

Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Medium, Systemic: Nausea-Severe, Systemic: Shakiness-Severe, Systemic: Visual Changes/Disturbances-Medium, Systemic: Vomiting-Mild

pt's mother states patient was instantly sleepy, waited 30 minutes inside tented waiting area, walked to car and became difficult to arouse/respond.

losing vision; almost passing out; After second dose: fever; chills; headache; body ache; pain at injection site; dizziness; This is a spontaneous report from a non-contactable consumer (patient). An 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 09Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation, at 18 years old. The patient medical history was not reported. There were no concomitant medications. No other vaccines if four weeks. Patient received the first dose of bnt162b2 at 12Mar2021 16:30, arm left for covid-19 immunisation, at 18 years old. Patient is not pregnant. The patient experienced after second dose: losing vision, almost passing out, dizziness, fever, chills, headache, body ache, pain at injection site on 10Apr2021 00:00 (12AM). Treatment was not given. Outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Severe soreness and stiffness within one hour of shot. Fatigue after two hours, still prevalent 8 hours later

PMS symptoms (bloating, headache, acne, cramps, tender breasts), delayed or possibly missed period, headache directly after getting first dose of pfizer, sore arm.

Patient developed an exanthem which developed within 48 hours of receiving #1 COVID vaccine. Rash was raised, and pruritic and started near her ankles. It spread to full-body rash within 24 hours, associated with low grade fever, angiodema of her lips. She treated herself with Benadryl , topical hydrocortisone and her daily Zyrtec. She was treated by healthcare professional with oral steroid for a 5 day course

symptom started 4/21, with pain and tightness in the left arm, progressively spreading up the arm over the following 48 hours, and then to the distal right arm, and legs. The leg symptom were present when seen 5 days ago, though were not discussed as Patient wasnt sure if thats what was really starting. This is associated with a feeling of "not being able to feel muc" and "doesn't feel right", as if it "feels foreign... body says this is weird," and feels heavy. Also notes that different extremities feel different - left is worse than right. Seen 5 days ago, and noted to have been advised by hematology to stop eliquis approximately 2 weeks prior to onset of symptom after PE/Renal artery embolism 1/2021. At that visit was referred to ER, where workup for repeat clot was normal (CTA, b/l upper extremities dopplers, head/neck CT, CXR). EKG was notable for Sinus tach and nonspecific T wave abnormalities. Discharged home with close follow up. Since then the intensity of the symptom as worsened and the leg symptoms have gotten more pronounced and consistent with the upper extremities symptom. Today notes new difficulty getting dressedon because clothes were getting stuck/he couldnt pull them down. Also notes when his left arm is touched it causes burning pain that shoots up the arm. Reports headache. 2-4/day, last 30 minutes, 5/10 in severity. Worse with movement of head. Frequent nausea, no emesis. but not specifically associated with headache. No waking from sleep. Since PE, has complains of intermittent left sided squeezing chest pain, which he wonders may be due to his anxiety. Lasts a few minutes Received Pfizer COVID vaccine 3/29, hasnt received 2nd dose yet ROS: general: no fevers or weight loss. CHRONICALLY C/O FATIGUE AND TROUBLE FOCUSING. has had evaluation for executive function difficulty in the past (interdynamics), now purusing evaluation at Neurology and awaiting EEG with this. HEENT: no sore throat. + VISION CHANGES - TROUBLE FOCUSING, but not specifically blurry vision. CV: LEFT SIDED CP, NONSPECIFIC T WAVE CHANGES ON LAST EKG W/SINUS TACH. Pulm: SOB, with walking up and down stairs, since PE. not worsening. No Cough. GI: +NAUSEA, no vomitting, no abdominal pain. No current diarrhea. Neuro: + HEADACHES. + SENSORY CHANGES. + family h/o MS

Headache, Fever, Chills, Muscle pain and hard time breathing. Fatigue. Currently treating with Tylenol and Ibuprofen and rest.

I was on my menstral cycle and the cramps were more intense. Dizziness and feverish though no fever. Tired and pain in shot arm

Low grade fever 100.4 approximately 8.5 hours after vaccine administered. Severe body aches - complained that bones hurt, especially ribs and legs. Rapid heart beat on. and off for 24 hours. Injection site pain for 30+ hours.

After the first shot on 4/4/21 i felt a little sick for a day and after 3 weeks i got a bump on my neck above my collarbone on the same side where i got my shot. After the second dose on 4/25/21 i felt very sick for about a week and the lump is still there

After about 6-8 hours I began to have flu-like symptoms such as feeling feverish, feeling achy, & having a headache. I also felt like it was hard to breathe. But, today May 3rd, 2021, 2 days after the vaccine I developed a rash on my left side (vaccine side) from my armpit down to the top of my ribs. It?s red & looks & feels like sunburn.

About 24 hours after the vaccine, at 2 PM, I had body aches and mild nausea. The body aches and nausea increased over the course of the day and by about 7 PM I also had a mild fever of 99.7 F. I still felt sick and feverish when I went to sleep a little past midnight, but I was fine when I woke up at 9:15 AM.

Adverse events: Extreme chest pain, couldn?t move arms very much, hands went numb and tingly, throat pain Treatment: went to the doctors and the hospital and have tried over the counter pain medicine which didn?t work, prescribed prednisone which didn?t work, prescribed naproxen 500 which didn?t work, prescribed famotidine which didn?t work, all blood and heart and lung tests came back fine Outcome: still in a lot of pain and nothing is helping and nobody can figure out what is wrong

her eyes are currently very puffy/swollen, watery and itchy; her eyes are currently very puffy/swollen, watery and itchy; her eyes are currently very puffy, watery and itchy; her eyes are currently very puffy, watery and itchy; She says she has the other normal side effects like a headache; This is a spontaneous report from a Pfizer-sponsored programt. A contactable consumer (the patient) reported that an 18-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number for second dose: EW0162 or EWO162, expiration date: 30Jul2021, NDC number: 59267-1000-02) via an unspecified route of administration in left arm on 14Apr2021 19:15 at age of 18-year-old at 0.3 mL, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. No family medical history relevant to AE. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8730) in left arm on 24Mar2021 at age of 18-year-old at 0.3 mL for COVID-19 immunisation and experienced no event (reported as "no AE following prior vaccination"). The caller declines being sick at the time of vaccination. No relevant tests. She said her eyes were currently very puffy/swollen, watery and itchy, start date 15Apr2021 ongoing improved. She said she had the other normal side effects like headache, start date 15Apr2021 ongoing improved. She did not elaborate on any other side effects. She said she was wondering what to do about her eyes, they were still swollen. She said she took an allergy pill to help that the pharmacist told her to take, her eyes were still somewhat swollen. She asked if she should call her doctor. The outcome of the events was recovering. No follow-up attempts are needed. No further information is expected.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Mild

Fever or Chills Cough Shortness of Breath Difficulty breathing Fatigue Muscle or body aches Headache Sore throat Congestion or running nose Nausea or vomiting Diarrhea

Approximately two minutes after vaccine injection, pt started to feel dizzy, saw spots, felt like she was going to pass out. Someone got a wheelchair and we took her back to observation/treatment area. Patient was very drowsy, felt nauseous, hands were tingling, and was cold and clammy. We asked her to text her Mom, who was sitting out in the parking lot, to have her come inside. Pt reported passing out with HPV vaccine and on blood draws. We moved patient to pt bed and took vitals (listed below). Patient was able to recover without any medication administration under close observation. After about 20 mins in obs/treatment area, she was feeling better and we moved her to the observation room with her Mom. We had leftover vaccine syringes, so Mom received her first dose of vaccine. They waited together until Mom's 15 mn obs time was over. Patient and someone left the clinic feeling fine and under their own power around 1845.

Patient became very pale and whole body sweating. Patient reported ears ringing and black spot in vision. Also, said arms were tingling. lasted approximately 15 minutes

At 10 minutes post-vaccination, patient had noted a dry, scratchy feeling in her throat and asked if I (mom) had brought a water bottle with us (I had not). At 20 minutes post-vaccination, patient began feeling her throat tightening, tongue swelling, and stated that her lips/mouth/tongue had a tingling sensation. At this point she was taken to the nurse/paramedic to be monitored with EKG, pulse oximetry, and given a bottle of water to drink. After 30 minutes of monitoring, the nurse/paramedic asked patient if her symptoms were improving and if she felt well enough to go home. She said that her symptoms were not gone, but improving, so she was told to sign a waiver/refusal of care form and released. However, at 11 hours post vaccination (1:30 AM), the symptoms returned (tongue swelling, throat tightening, tingling sensation in and around her mouth). I administered Benadryl (2 tablets), monitored for 30 minutes, and symptoms improved. No further symptoms after that point.

I ran a fever the night following the vaccine. Between the times of 11 pm and 10 am, I would run a fever and it would break and repeat. It always broke on its own and eventually stopped all together.

8:00pm - left arm soreness 2:00am - chills, difficulty sleeping 9:00am - tiredness, body aches, fever 12:00pm - felt mentally out of it 11:00pm - throat soreness

Patient received the 2nd dose of the Pfizer COVID-19 Vaccine in her left arm on 4/28 at 12pm. At 9pm that even she developed symptoms of heaviness, weakness, numbness, tingling and intermittent pain from her left upper arm to her left hand and fingers. She had fever for 2 days. The symptoms resolved after 48 hours. She started having the same symptoms in her left upper arm to her fingers yesterday. She started to have right lower leg pain, numbness and tingling yesterday. She has had no chest, pain, cough, SOB, headaches, blurred vision, dizziness or fever. She has no neck or back pain. She has no rash or bruising. She received the first Pfizer Vaccine on 4/7/21.

Systemic: Confusion-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Feeling of passing out, in and out of consciousness, general weakness, sweats, weakness in breathing-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Severe, Systemic: Weakness-Severe

Shortness of breath, dizziness, faint, anxiety, headache and arm pain. Transported to ER and not able to reach patient for follow up.

5/5/21 Wednesday - got 2nd Pfizer Shot. 5/6/21 Thursday - 2am awoke with shakes/chills and throughout the day had body aches, temperature increased from 98.6 to 101.2, stiffness, nausea, headache, chills and sweats. 5/7/21 Friday symptoms continued from previous day but had strong abdominal pain. I went to my doctor and they suspected I could have appendicitis and also symptoms from the vaccine. They suggested going to the ER after 3 days if systems persisted. I went home after the doctor visit and was nauseous. I had sprite, ate white rice and chicken broth. My abdomen felt a bit better but I had a bad headache. 5/8/21 - Saturday I awoke at 6am with stabbing/burning chest pain that increased as time progressed. The chest pain was increasing and getting worse after 1 hour and 30 minutes. The pain was in the middle of my chest. My mom took me to the Emergency Room.

On 5/9 at approx 8 or 9pm patient started experiencing a severe headache. Given her history of allergies and angioedema, I had her take 25 mg of oral Benadryl in addition to 500mg of Tylenol. This morning (5/10) when she woke up her upper lip was severely swollen. This sometimes happens with her angioedema, but it is always unilateral, stopping abruptly at midline. This time the swelling was bilateral, involving the entire upper lip, and was more severe than she has ever experienced. She took 240mg Allegra and 40mg Prednisone per MD instructions. Swelling started improving in the afternoon. Patient has known triggers for angioedema, but had none recently, nor had she experienced any angioedema in the last few months.

Came to location for Pfizer vaccine on 5/4/21. She had a vasovagal reaction immediately after the vaccine. Her B/P was 122/62. She was pale and diaphoretic. She was seen by Dr. She recovered after a brief period and went home.

Woke up fatigued the next day with a headache and soreness extending to the left side of my chest and back. My head feels like it's stuffed with cotton and it takes a second to process what people are saying to me.

Pt received vaccine soon after began to c/o syncope episodes. Pt able to walk to cot and lay down. No sob noted. Pt cold and clammy. 911 called paramedics out to assess pt refused to go to hospital. after 30 minutes pt began to feel better. 1st set V/S 530 pm p-88, 02 sat 97, BP 104/80 waited 1.5 hrs for husband to pick pt up. Pt stable no c/o no distress able to ambulate on own home with husband.

slight chills; cold; Extreme nausea/slightly nauseous; Extremely fatigued; Dizzy; Shakiness; Fever/ 101.6 fever/temperature was 100.3; Dehydration; Headache; Muscle ache; Arm pain; Pain; This is a spontaneous report from a contactable consumer. A 18-years-old non-pregnant female patient received bnt162b2 (Pfizer, Solution for injection, Lot Number: EL9264), dose 2 via an unspecified route of administration, administered in arm left on 06Feb2021 12:45 (at the time of 18-years-old) as second dose, single for covid-19 immunisation. Medical history included partial aortic bicuspid valve, aortic dialation, sulfa wellbutrin allergies (known allergies) and postural orthostatic tachycardia syndrome. No other vaccine administered in four weeks. The patient had not covid prior vaccination. The patient had not tested positive for covid post vaccination. Concomitant medication included ethinylestradiol/ferrous fumarate/norethisterone acetate (JUNEL FE) for an unspecified indication, from an unspecified date and unknown if ongoing. The patient previously took bnt162b2 (Pfizer, Lot no EL8982,Administration time=12:15 PM,Vaccine location Left arm, Dose no 1) on 16Jan2021 for COVID-19 immunisation. She received the vaccine at 12:50 PM and my temperature was 98.6 with no symptoms. At 1 am, her temperature went up to 99.6° and a headache, muscle aches and slight chills started. At 4:20 AM, woke up with a 101.6 fever, extreme nausea, dehydration and shakiness. In the morning at 9:00 AM temperature was 100.3 and when I got up around 12:00 PM, was extremely fatigued, dizzy when standing, and slightly nauseous which made it hard to eat normal foods. At 1:20 PM, temperature was 100.7. At 7:00 PM, nausea subsided slightly and was able to eat normal foods. At 10:00 PM, cold chills began in and at 11:00 PM, temperature was 100.4. The next day (08Feb2021), my temperature was at 97.8 upon awakening and felt dizzy, tired and winded with regular activities throughout the days but no fever. By the next day (09Feb), patient was completely syptom free. Arm pain was very minimal, pain level 1, on the day of vaccination and the day after and gone after that. The patient underwent lab tests and procedures which included body temperature: 101.6 (at 4:20 patient temperature was 101.6), 100.3 (at 9 temperature of patient was 100.3), 100.7 (at 13:20 patient temperature was 100.7), 100.4 (at 23:00 patient temperature was 100.4), 99.6 (at 13:00 patient temperature was 99.6F) on 07Feb2021, and 97.8 (patient temperature was 97.8) on 08Feb2021. The patient not received treatment for events. The outcome of events recovered on Feb2021.

Patient had right sided facial redness and itchiness about 20 to 30 minutes after injection, no swelling, no rash, that lasted about 10-12 hours, patient then had right periorbital swelling about 1-2 hours after injection, with slight scleral injection and itchiness of the eye, this lasted about 24 -36 hours then resolved completely Flu like symptoms ( body aches, fever, chills) within 24 hours that last about 36 hours post vaccine

Fatigue and mild severe pain in the right armpit. A little pain at the injection site. Been feeling the armpit pain since the morning after the vaccine.

Redness at injection site (Wednesday-Thursday), swelling at injection site (Wednesday-Thursday), muscle pain (Wednesday-today), hives on left arm (Wednesday-Thursday), headache (Thursday-today), nausea (Thursday-today), vomiting (today) , diarrhea (today)

per pt's dad, about 1 minute after vaccination, client stated she was not feeling well. She was then observed unconscious for about 60 seconds.

Headache; soreness at injection site; extreme muscle and joint pain; extreme muscle and joint pain; mild fatigue; This is a spontaneous report received from a contactable consumer (patient). This non-pregnant 18-year-old female patient received the second dose of COVID-19 vaccine (UNSPECIFIED TRADE NAME; lot number EW0153) via an unspecified route of administration in the right arm on 15Apr2021 at 08:15 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination the patient had not been diagnosed with COVID-19. Concomitant medications included sulfamethoxazole, methylphenidate hydrochloride, and sertraline, all from unknown dates for unknown indications. The patient previously received the first dose of COVID-19 vaccine (lot number EP6955) on 25Mar2021 at 08:15 (at the age of 18-years-old) for COVID-19 immunisation. The patient had not received any other vaccines in the four weeks prior to the COVID vaccine. On 15Apr2021 at 16:00 the patient experienced headache, soreness at injection site, extreme muscle and joint pain, and mild fatigue. No treatment was received for the events. The clinical outcomes of headache, soreness at injection site, extreme muscle and joint pain, and mild fatigue were unknown. It was also reported that since vaccination, the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.

Prior to vaccination, the patient reported a history of feeling light headed during and immediately after procedures involving needles. Patient completed pre-screening checklist for Pfizer COVID-19 vaccine and was administered 0.3mL of Pfizer BioNTech vaccine IM in left deltoid at 3:28pm. At 3:30pm patient began to appear pale and lethargic. Patient reported that she felt light headed and dizzy. Patient's mother encouraged her to drink water. Patient was assisted to lie down on ground. The first set of vital signs were taken at 3:34pm. Pulse was 68, regular and thready. Respiratory rate was 12 breaths per minute and unlabored. Blood pressure 73/43. Oxygen saturation 98%. Pt reported soreness in left arm and no other pain. An ambulance was called. At 3:40pm, vital signs were PR 71, RR 12, BP 86/59, O2 Sat 98%. Patient reported minor nausea. At 3:45pm vital signs were PR 71, RR, 14, BP 106/70, O2 Sat 96%. Patient reported a headache. Ambulance arrived at 3:48pm. Patient was assisted to stand and walk 10 feet to stretcher. Ambulance Unit transported patient to Hospital.

Post vaccine pt stated she started coughing, got scared. pt admin Epi-pen to right thigh per self then notified medical staff of s/s. VS 1051- 120-80, 78hr. No studder, wheezing noted. BS clear BLT. HR regular. Pt requested to go to ER via ambulance 911 called by fire dept . loss- BP 120/80 hr 118Resp 24, pt transported via ambulance at in stable condition. Pt mom is aware

5 minutes after administration, she started having a headache and then nausea. Afterwards she felt hot and was shaking. She reported chest pain. Vitals were stable. EMS transported her due to inability to reach parents and inability to drive herself home.

5 minutes after receiving the vaccine, she reported headache, nausea, shaking, and some chest pain. Vitals were stable. Transported by EMS due to inability to reach parents or drive herself home.

Back pain requiring Naproxen, canker sore outbreak in mouth followed by same type of sores in genital area, headaches, spiked temperatures, chills, sweats, body acne, fatigue. Back pain, headaches & fatigue continue today; genital sores and acne improved after several weeks; mouth sores lasted over a month but better now.

Systemic: Fainting / Unresponsive-Medium, Systemic: Headache-Mild, Additional Details: got emotionally excited after shot fainted for 25 seconds, patient was tired bur responsive

This is a 18 Years old Female presenting with chest pain for [a couple hours last night]. Pain started [gradually]. It is described as [dull and aching], radiating into [nowhere]. Pain is described as [moderate] upon onset and is currently [mild]. [No] history of the same. Pain [is not] worse with exercise. Patient [has no] decrease in exercise tolerance recently. Patient states that she received her second dose of her Pfizer vaccination 3 days ago, and last night she started to experience chest pain, headache, palpitations, and shortness of breath, and feeling dehydrated.

Patient had syncopal episode approximately 1-2 minutes after receiving injection of vaccine. Slumped over in her chair, lost consciousness for approx 30-60 seconds. Regained consciousness, diaphoretic, slow to respond. Heart rate dropped to 44 bpm. Blood pressure 80/58. Sp02 90%. Nursing staff assisted pt to reclining position, called EMS for assistance. Monitored vital signs until arrival of EMS. Pulse and BP gradually returned to normal range. LOC assessed, pt remained in clinic until recovered. No transport needed.

POST VACCINATION DURING 15 OBSERVATION PERIOD, PATIENT BECAME DROWSY AND APPEARED TO POSSIBLY PASSOUT BRIEFLY. LAYED PATINET DONE, CALLED 911, PATIENT WAS AWAKE, ALERT AND DRINKING WATER, BUT DROWSY, MEDICS EXAMED AND PATIENT REFUSED TRANSPORT TO HOSPITAL. PATIENT LEFT WITH HER MOM

FE Viral illness Cough Sore throat Fever in other diseases Exposure to COVID-19 virus VER Muscle or body aches and Headaches, sore throats

-Bleeding from vagina (I don?t start my period for another two weeks) -Nose bleeds -Heat flashes (feels like a fever) -Gets cold really easily (shivering and chattering teeth) -Large rash on arm -Unable to eat as much -Fainting -Stomach ache -Headaches

Patient was administered Pfizer COVID-19 vaccine and fainted during her 15 minute observation time. Mother alerted pharmacy staff. Pharmacist observed patient regain consciousness. Patient reported feeling warm, was sweating, and saw spots of light. Patient was given a bottle of water and and instant cold ice pack. Patient observation time was continued. After fifteen minutes patient was feeling better and left pharmacy with mother.

The first dose of the vaccine went fairly well aside from fever, muscle aches, and pain in the left arm at the injection site. The second dose was reportedly worse. The fever ranged from 104.8 degrees Fahrenheit as a high and 102 degrees Fahrenheit being low, which receded after 3 days of care. In addition, chest pains and heart pain started at 8:00pm the day of the vaccination which was completed at 11:15am. Pain at the injection site and overall body muscle aches lasted for 3 days. The heart/chest pains have yet to recede. Instead it is occurring more frequently in ?bursts? of pain with a constant aching sensation.

Per client noticed redness and itchiness on right arm where she received vaccine 1 day after. Per client is resolved on its own, did not take medication for this. Client also reported throat itchiness on day 2. Client denied shortness of breath. Per client took ibuprofen and symptom resolved by day 3. Client stated not following up with provider as it resolved on its own. Medical history of seasonal allergies and takes over the counter medication for allergies and fiber for digestion.

One day after receiving the first dose of the SARS-CoV-2 vaccine the patient developed headache, neck pain, and fever. Her symptoms persisted for 2 more days and she then presented to the hospital where she was diagnosed with meningitis with a CSF WBC of 8. Her infectious work up of the meningitis has not revealed the cause to date.

Patient's mother called us on 5/28 to inform us that her daughter received the Pfizer vaccine on 5/16 and started having symptoms on 5/22: Swelling of lymph nodes, breasts, and what felt like her throat, a fever of 102F and felt like her heart was pounding. Patient's mother states that her heart is no longer pounding but is still having swelling and fever.

Problems with her heart; Shortness of breath; Pain the chest; Low blood pressure; Passed out; Started shaking "like a seizure"; Started shaking "like a seizure"; Dizziness; Tiredness; Stomach pain; Chills; Fever; Sweats; Nausea; Vomiting/throwing up; Inflammation in the chest, muscle or maybe heart inflammation; Inflammation in the chest, muscle or maybe heart inflammation; Inflammation in the chest, muscle or maybe heart inflammation; Pain in the heart; Not feeling well; Had a severe allergic reaction; Headache; Weak; This is a spontaneous report from a contactable consumer (patient's mother). An 18-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0169; Expiration date was not reported) on the left arm on 20Apr2021 as a 1st dose, single dose, with route of administration unspecified, for COVID-19 immunization. The patient had no relevant medical history and concomitant medications. On 20Apr2021, the patient had passed out; started shaking "like a seizure"; dizziness; tiredness; stomach pain; chills; fever; sweats; vomiting/throwing up; and nausea. The patient was brought to urgent care/emergency room (ER) due to the reported events. On 21Apr2021, the patient had shortness of breath; pain in the chest; and low blood pressure. On 22Apr2021, the patient had problems with her heart. The patient was brought to urgent care/emergency room (ER) due to the reported events, and for cardiac work up. On an unspecified date in 2021, the patient was not feeling well; had a severe allergic reaction; headache; and was weak. In Apr2021, the patient had "inflammation in the chest, muscle or maybe heart inflammation". The patient received treatment for the events, pain in the chest and "inflammation in the chest, muscle or maybe heart inflammation" (double dose of naproxen. The patient's laboratory tests included normal blood pressure on 22Apr2021; chest x-ray on 21Apr2021 (results were not provided); echo sonogram on 22Apr2021 (results were not provided); electrocardiogram (EKG) was normal on 21Apr2021, 22Apr2021 and 23Apr2021. The outcome of the events was not recovered for tiredness; was recovered on an unspecified date in 2021 for chills, sweats, vomiting/throwing up; was recovering for pain in the chest; and was unknown for all the other events. The patient's primary care provider was writing a doctor's note recommending that she not receive the second dose based on her reaction to the first dose, and the PCP recommended that the mother call Pfizer as well.

arm hurting, sore arm; vaccine was mixed with sterile water instead of saline; vaccine was mixed with sterile water instead of saline; felt unwell after her 2nd dose; tired and does not feel great; This is a spontaneous report from a contactable consumer (patient's mother). An 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot Number unknown, expiration date unknown) 2nd dose, single dose, via an unspecified route of administration on 18May2021 11:45, for covid-19 immunization (at the age of 18-years-old). Medical history included covid-19. It has been a couple of years since patient had not received any other vaccine. There were no concomitant medications. The patient previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot number unknown, expiration date unknown), via an unspecified route of administration on 27Apr2021, as single dose for covid-19 immunization at the age of 17-years-old and had really high fever, ears really hurting, Ears got so puffy and filled with fluid. It was stated, that her 18-year-old daughter already received both doses of the Pfizer-BioNTech Covid-19 Vaccine. She said her daughter was 17 years old when she received the 1st dose, but was 18 years old when she had her 2nd dose. She said her daughter had a really bad reaction to the 1st dose, and also felt unwell after her 2nd dose. The reporter stated that on 18May2021 11:45 the patient received second dose of vaccine and stated that someone from pharmacy told that patient's vaccine was mixed with sterile water instead of saline and after receiving the vaccine the patient felt unwell and she was tired and does not feel great on an unspecified date in May2021 and on 19May2021 patient's arm was hurting and had sore arm. Reporter wanted to know if her daughter gets revaccinated or whether she was still fully vaccinated. She was referred to her health care provider for that information. Pfizer has not tested the effects of using sterile water for injection as the diluent for the current formulation of the Pfizer-BioNTech COVID-19 Vaccine. The diluted vaccine using sterile water for injection as the diluent should be appropriately discarded and not used for vaccination. The Pfizer-BioNTech COVID-19 Vaccine has not been tested with sterile water for injection as the diluent. The outcome of the events was unknown. Information on Lot/Batch number has been requested.

Cough; Headache; Fever; Chills; Fatigue; This is a spontaneous report from a contactable consumer (patient herself). An 18-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration in right arm on 28Feb2021 at 11:30 (at the age of 18-year-old) as a single dose for COVID-19 immunization. The patient's medical history included known allergies: Nuts, shellfish, sesame. Concomitant medication included etonogestrel (NEXPLANON), received within two weeks of vaccination. The patient did not receive other vaccine in four weeks. No COVID prior vaccination. The patient has not been tested for COVID post vaccination. On 28Feb2021 at 14:00, the patient experienced headache, fever, chills, fatigue. Cough on day 4 (04Mar2021). No treatment medication was received for the adverse events. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot been obtained.

within 34 hours of the 2nd dose of the Pfizer Covid shot, patient began to break out in welts/hives behind her knees. She woke up in the middle of the night with her scalp itching and her ears hot as well as the welts behind her knees. Given Benadryl which helped a little for about 2 hours but then the hives just kept spreading and growing into huge swollen itchy patches on her body. By Friday afternoon, she had tried Benadryl and calamine lotion only to have it continue to get worse. We ended up with the Urgent care by 4pm Friday, 4-30-21. They gave her Prevacid and prescribed steroid cream. They told us if it got worse or affected breathing to go ER. We went home and kept taking the benedryl every 6 Hours and using the steroid cream. as one welt would begin to disappear, others would pop up. the steroid cream did not help in that regard. the benedrul would give about 50% relief for about 2 hours before the itching got very bad. Unable to sleep to do anything, we took patient to the pediatrician that Sat morning 5-1-21. She examined her and told her to take Claritin in the morning and Zyrtec at night to help. She was hestiant to prescribe any steroids due to unknown interaction or affects with the Covid shot. She told us to keep checking in with her and also if it got worse or spread to her face/mouth or any trouble breathing to go to the ER. We went home and tried to take an oatmeal bath. It only made things worse. By 10pm that Sat night 5-1-21, the hives had spread to patient's face and lips and were affecting her throat. Her voice got very raspy. we decided at that point to take her to the ER. They started her on steroids that night. She continued taking the steroids for 5 days after that. The steroids did help make her hives go away. However, within 2 days of finishing the steroids, patient noticed that she still did not feel 100%. That Saturday 5-8-21, She began to feel light-headed and off. She also began to feel fatigued. She came home from an errand needing to lay down and feeling dizzy. A few days after that, she began to have gas and indigestion, feeling like something caught in her throat and feeling nauseous. She also noticed that there a few nights in all of this that she would wake up shivering for no reason. The shivering would continue until she woke up in the morning. This report is being filed on 5-30-21. Since her 2nd shot and after the hives, we have been dealing with ongoing dizziness, fatigue, tiredness, lightheadedness and nausea to varying degrees. She has not been able to resume regular activates of being active or working out. WE have been back to the dr.

The night following injection, the patient experience increased anxiety, chills, possible fever, headache, backache, generalized muscle aches, and abnormally vivid dreams throughout the night. Monitoring of symptoms is continually being addressed by the patient's mother.

Pfizer-BioNTech COVID-19 Vaccine . Tiredness, headache, muscle pain, chills, fever. The symptoms lasted for 24 hours.

Headache; Fever; strong pain in the chest; This is a spontaneous report from a contactable consumer (patient's mother). An 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number unknown) via an unspecified route of administration on 24May2021 as 2nd dose, single (at the age of 18-years-old) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had no effects, but patient went to bed early at 20:00 last night and did not mention anything. On 24May2021, patient experienced headache, fever, strong pain in the chest. Patient still felt pain in chest. Outcome of the events was unknown. Information on the lot/batch number has been requested.

Approximately 10 minutes after the shot, patient reports not feeling well, rapid heart beat, shakiness, and has difficulty breathing (feels like her throating is closing up). Gave one dose of 0.3 mg Epi-Pen 15 minutes after the vaccine. Called paramedics and arrived at 5:35 pm when patient was taken to the hospital. Patient was alert when she was picked up by the paramedics.

36h after "broke out with hives and patches all over the body with extreme itching; 36h after "broke out with hives and patches all over the body with extreme itching; her ears turned red and became very hot, the hives spread to her face and into the throat; her ears turned red and became very hot, the hives spread to her face and into the throat; gastrointestinal issues; very gassy feeling of something stuck in the throat; skaes and shivered out of blue; felt lightheaded and dizzy with extreme fatigue; felt lightheaded and dizzy with extreme fatigue; nausea; This is a spontaneous report from a contactable consumer (Patient's Mother). An 18-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation solution for injection; Lot number was not reported), via an unspecified route of administration, on an unspecified date as 2ND DOSE,SINGLE DOSE for covid-19 immunization. The patient's medical history included Hashimoto's Disease. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 on 31Mar2021 for covid-19 immunization and experienced severe indigestion, vomiting and did not feel well. On an unspecified date (36 hours after receiving the second dose of vaccine), the patient broke out with hives and patches all over the body with extreme itching, her ears turned red and became very hot, the hives spread to her face and into the throat. The patient was prescribed steroid creams, and she self-administered three antihistamines included Zyrtec, Claritin, & Benadryl. The hives went away. After that on an unspecified date, the patient had gastrointestinal (GI) issues, she had very gassy feeling of something stuck in the throat, and had nausea to the point of being unable to eat. Also, she shivered and shakes out of the blue, felt lightheaded and dizzy with extreme fatigue. The patient received treatment with steroid creams, and antihistamines included Zyrtec, Claritin, & Benadryl for the events 36h after "broke out with hives and patches all over the body with extreme itching and her ears turned red and became very hot, the hives spread to her face and into the throat. The caller (reporter) mentioned that she heard that the vaccine causes problems in fertility hence caller asked for information on fertility studies with regards to the vaccine in response she was explained reports on the possible side effects, mentioned no information found for non-reported AEs, and referred to health care professional (HCP) for further guidance. Further, caller asked for information on how to treat or go about with the side in response she was informed that Pfizer was unable to make treatment recommendations specific for individual patients and referred to HCP for further guidance. Again, Caller asked, "how the vaccines work" in response she was explained about vaccine mechanism and CDC information. Caller asked if there was a way to measure the spiked proteins in the body as caller wanted to know how to measure/assess immunity after vaccination in response she was being explained about CDC recommendation, and referred to HCP for further guidance. Moreover, caller asked if there were other proteins in the body/organs/cells that were similar to the spike protein that our body could possibly react to in response mentioned that no information found on body components similar to the SARS-CoV2 Spike Protein, and she was referred to HCP for discussion. Caller complained and mentioned "reporter don't think all this information is being made public, it just seems to me like the issues for the vaccine is much worse for her than as if she got COVID19. Reporter really hope that the Doctors/ CDC / Pfizer and all organizations would reconsider this, especially on the possibility on the issue on the body attacking its own self." The outcome of the event hives was considered as resolved while the outcome of all other reported events was unknown at the time of this report. Information on Batch/Lot number has been requested.

severe indigestion; vomiting; did not feel well; This is a spontaneous report from a contactable consumer or other non hcp. This is a split case of 1st dose. An 18-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number and expiration date were not reported), dose 1 via an unspecified route of administration, administered in left arm on 31Mar2021 given in the late afternoon as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included autoimmune thyroiditis (Hashimoto's disease) from Jan2020 and ongoing for which no medications were given for it though and family history of autoimmune disorder (autoimmune disease) from an unknown date and unknown if ongoing which run on both sides of the family. Sister also has Hashimoto's disease. Concomitant medication included ergocalciferol (VIT D) taken for vitamin d deficiency from Jan2021 and ongoing. No prior history of vaccination before the first dose of COVID-19 vaccine. However, reporter stated that, once when patient was a baby she was inconsolably crying after a set of shots, but nothing else as she knew of. After the first dose of Pfizer-BIONTECH COVID-19 Vaccine, the patient experienced severe indigestion, vomiting and did not feel well on 07Apr2021. Reporter mentioned that it just seems like the issues for the vaccine is much worse than COVID19. And that the Doctors/ CDC / Pfizer and all organizations would reconsider the possibility on the issue on the body attacking its own self. It was reported that patient was having strange side effects and reporter was trying to get more info on how to possibly treat it. The reporter stated that after the first dose, about 6 days later, patient had terrible indigestion and vomited. It was out of the blue and then patient felt better. Patient was very healthy without health problems, no GI issues, and has not thrown up since she was 8 years old. The reporter said that patient had no allergies, and this was strange for her. By about 07Apr2021, patient did not feel well in the evening, had terrible indigestion, and vomited. This eventually got better and seemed to go away after that. No investigation assessment and relevant tests were done. The outcome of the event vomiting was recovered on unspecified date and the other events were recovering at the time of this report. Information about Lot/Batch number is requested.

Systemic: Flushed / Sweating-Medium, Additional Details: at 12:11pm pt was sweating and very hot, turned on fan whil ewaiting for 15min, pt left with mom at 12:36pm no other issues reported

fell straight over on her face, hitting her chin and splitting it open; felt dizzy; cold sweating; panic attack; significant memory loss; mild concussion; dehydration; fell straight over on her face, hitting her chin and splitting it open; insufficient food intake (had not eaten yet); felt more sick then usual; This is a spontaneous report from a contactable consumer. An 18-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8736, expiration date: not reported), via an unspecified route of administration on 14May2021 as single dose for Covid-19 immunisation (Age at Vaccination: 18years). The patient medical history was not reported. Concomitant medications included fluoxetine hydrochloride (PROZAC) 10mg/day (as medications in two weeks) taken for an unspecified indication, start and stop date were not reported. No known allergies and no other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On 15May2021, the patient felt dizzy, had cold sweating, was scared, and thought she was having a panic attack but felt more sick than usual. On 15May2021, the patient stood up from couch, walked 15 - 20 steps and then fell straight over on her face, hitting her chin and splitting it open; she was conscious when rolled over by her parents but had significant memory loss (knew her name but not her school grade or which classes she was taking). She was taken to the hospital, computerized tomogram (CT) Scan, electrocardiogram (EKG) was normal, and no evidence of seizure were there. On 15May2021, the patient was diagnosed with mild con-cussion and got stitches on the chin as therapeutic measure for her chin splitting. Doctor suggested dehydration may had been a factor, also insufficient food intake (had not eaten yet) (start date: 15May2021). The patient stayed home from school for a week with memory improving each day and still did not remember completely a period of 48 hours starting around time of vaccination however, other symptoms had resolved. The patient had never fainted before. The treatment for rest of events was unknown. The patient underwent lab tests and procedures which included CT scan and EKG both as normal, both on 15May2021. The outcome for mild con-cussion and significant memory loss was recovering; and rest all events were resolved.

Patient responded well to first dose of COVID vaccination, but after second (administered 4/30/2021) developed persisting nausea x5.5 weeks, intermittent diarrhea and vomiting. She has been afebrile. One ED visit for IV fluids due to dehydration, but has been tolerating fluids since then, minimal food intake.

First I got a sore throat and felt really tired. Next, I woke up with a headache and a low-grade fever that lasted most of the day.

That night I was feeling groggy in the head which I knew is a normal side effect. But later that night I couldn?t go to sleep and began to shake all over my body. I did not have shortness of breath, or heart pains- I just couldn?t stop shaking. I tried to control my breathing to help but it did nothing. After the shaking stopped I tried to sleep again but I threw up twice and could not fall back asleep.

she fell on the floor and become unconscious; she fell on the floor and become unconscious; She got sick; she lost all energy; She hurt her throat its like she can read but she has very heavy under her neck; She hurt her throat its like she can read but she has very heavy under her neck; This is a spontaneous report from a contactable consumer (Father). An 18-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, Batch/Lot Number: EW0185), dose 1 via an unspecified route of administration, administered in Arm Left on 28May2021 16:00 as 1ST DOSE, SINGLE for covid-19 immunisation. Patient Medical history and concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. It was reported that, On 28May2021 caller stated that we took our daughter to get vaccinated on 28th and she loss of conscious and she got sick, and it took almost 24 hours to recover so we need to get the forms, so she does not get her second shot and we do not want to have a second shot for her because of the lot reaction on her body. In the 22nd day later she fell on the floor and become unconscious, and she lost energy and you know it takes time to come up and it take 2-3 minute to come up and she lost all energy and she hurt her throat it's like she can read but she has very heavy under her neck. The event loss of consciousness, fall and illness was recovered on unspecified date in 2021.The event musculoskeletal discomfort oropharyngeal pain and asthenia was unknown. Therapeutic measures were taken Tylenol and green juice as a result of she fell on the floor and become unconscious (loss of consciousness), she fell on the floor and become unconscious, she got sick, she lost all energy, she hurt her throat it's like she can read but she has very heavy under her neck, she hurt her throat it's like she can read but she has very heavy under her neck (oropharyngeal pain). No follow-up attempts are possible. No further information is expected.

Small red rash appeared next to the injection site, my arm was sore. I felt achey, had a headache and a slightly upset stomach. I felt better within 24 hours.

Day 1: pain/swelling at injection site with redness, muscle aches, joint pain Day 2: pain/swelling at injection site with redness, muscle aches, joint pain, headache; worked but with considerable discomfort/strain Day 3: pain at injection site, muscle aches, joint pain, headache, chills, fatigue, feeling unwell, insomnia; unable to work Day 4: extreme muscle aches, joint pain, headache, chills, fatigue, feeling unwell, insomnia, fever, sweating, sore throat, diarrhea; unable to work; attempted to see doctor but was refused care due to "CoVid-like symptoms" Day 5: extreme muscle aches, joint pain, headache, chills, fatigue, feeling unwell, insomnia, fever, sweating, sore throat, diarrhea; unable to work Day 6: extreme muscle aches, joint pain, headache, chills, fatigue, feeling unwell, insomnia, fever, sweating, sore throat, nausea; unable to work; attempted to see care at Urgent Care but was turned away for having "CoVid-like symptoms;" went to hospital per the recommendation of MD and urgent care Day 7: mild muscle aches, fatigue, feeling unwell, insomnia, sweating, sore throat; unable to work Day 8: sore throat, mild fatigue, sweating; unable to work

patient c/o sore throat, feeling tired and muscle aches after vaccination. Has been taking tylenol and feeling better.

30 minutes after injection, had sore arm, "hurting" while breathing, increased heart rate, increased blood pressure; after arriving at ER, more than 1 hour after injection, had vomiting x 3, hives/welts on chest and arms, fever and chills

Patient reported no adverse event or allergies at pre-screening so received vaccine around 1:55pm and around 3.25pm patient reported of headache, SOB, faster heart rate, having to stop in middle of sentence, chest hurting breathing in . Emergency services was called and patient was assessed while waiting for emergency services to arrive. At 3.39pm BP 125/80 mmHg, 84 bpm and oxygen stat. 97%, again at 3.42pm oxygen stat. 98% and pulse 81bpm

I woke up this morning (approx 18 hrs post injection of my 2nd dose) feeling some myalgia, joint pain (perhaps 7/10 on a pain scale) and fatigue. I was able to work out (exercise bike 30 mins) and shower despite the pain. Then, around noon today (nearly 24 hrs post injection) I began feeling increasingly dizzy and warm. I stood to go to my bed and lost consciousness and collapsed. I was only unconscious for perhaps 15 seconds. I woke up feeling very shaky and cold and breathing rapidly. I was able to slow my respirations. My skin on my face and hands was very pale (lips were whitish blue). My housemate had called 911 for me: FD showed up and took a couple sets of orthostatic vitals. My BP when seated on the floor was around 110/80, pulse 80, and my BP when standing was around 90/70, pulse 100. I was able to walk to the bed without help so I decided to stay home and just hydrate, sleep, and keep a close eye on things. Now (1620, around 4 hrs after passing out). I still feel lots of soreness, but only very minor dizziness.

19 year old female reaction to Covid 19 vac; she is alert and orientated; complaining of rash, difficulty breathing, dizzy, lump in throat, headache, nausea, cough. 1 dose of Benadryl 25 mg given at 1430. Patient states she is medical fragile and has a HX of epilepsy. EMS called at 1500 evaluation mild allergic rxn will transport to hospital for further evaluation.

Pain in arm like a tents shot for about a day and a half; headache; dizziness; This is a spontaneous report from a contactable other hcp, the patient. This 19-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: EK4176) (dose #1), via an unspecified route of administration in the left arm on 04Jan2021 at 19:00 (at the age of 19-years-old) as a single dose for COVID-19 vaccination. Medical history included depression from an unknown date and unknown if ongoing, panic disorder from an unknown date and unknown if ongoing and a weak immune system from an unknown date and unknown if ongoing. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication included escitalopram oxalate (LEXAPRO) and an unspecified antiacid. On an unspecified date in Jan2021, the patient experienced pain in arm like a tents shot about a day and half, some headache and dizziness the first few hour. No pain or symptoms reported after 3 days following the vaccination first dose. No therapeutic measures were taken as a result of the events. The clinical outcome of pain in arm like a tents shot about a day and half, some headache and dizziness was resolved on an unspecified date in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.

Pfizer-BioNTech COVID-19 Vaccine EUA I did not experience any symptoms until the night following the vaccination. Around 3:30am (01/14/2021), I was awoken by intense chills. I was restless throughout the rest of the night, having hot and cold flashes. I woke up around 8:20am and felt that I had a subjective fever. I was also experiencing intense body ache and headache. I took my temperature and it showed to be 100.6ºF. I was still experiencing chills despite also feeling hot at the same time. After an hour, my temperature was 101ºF. I took 2 naproxen sodium tablets (440mg) to relieve fever. Around 10:45am, my fever reduced but my body ache and headache stayed at the same pain level. Around 2pm, I took 2 tablets of ibuprofen (400mg). My headache stopped around 8:00pm. My body aches stopped the morning of 01/15/2021.

Nausea/ Stomach cramps High fever (over 100) Both started night of injection and resolved over night with some help of Ibuprofen Patient had COVID-19 2 months prior to receiving vaccine.

Fever; headache; fatigue; nausea; muscle aches; This is a spontaneous report from a contactable nurse reported for herself. This 19-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 09Jan2021 15:30 at single dose (vaccine location=left arm) for COVID-19 immunization. Medical history included allergies: Iodine, shellfish. The patient had COVID prior vaccination. Patient was not pregnant, and did not receive other vaccine in four weeks. The patient's concomitant medications were not reported. On 10Jan2021 07:00 AM, the patient experienced fever, headache, fatigue, nausea, muscle aches. No treatment received for events. Patient had not tested COVID post vaccination. The outcome of events was not recovered. Information about lot/batch number has been requested.

Extreme muscle weakness/ache, chills and shaking. Began around 11pm on 1/19/21 and mostly cleared by 3pm on 1/20/21. Was severe enough to prevent working, paid or otherwise.

A few hours after the shot I felt fatigued and my arm was very sore. Later in the day around 3:00pm I got chills and muscle soreness throughout my whole body. I then started to develop pain in my chest while breathing and I was having to gasp for air(this was around 5:30pm). My skin (mostly on my back) felt like it was burning and itchy. That lasted the entire night. 24 hours after the injection and I am still feeling tightness in my chest when I breathe, sore throat, and sore muscles.

On the day I took the vaccine, my whole left side became sore and numb. The soreness and numbness continued on through the next day. Friday evening, I had the same symptoms coupled with nausea, headache, and chills. Saturday, I continued to have slight soreness and nausea. Today (Sunday), I'm still having a bit of soreness on my left shoulder where I took the vaccine.

headaches; Confusion; Fever; muscle aches all over; This is a spontaneous report from a contactable consumer (patient). A 19-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT#: EL0140), intramuscular in upper left arm on 11Jan2021 around noon at second single dose for preventative. Medical history included ongoing attention deficit hyperactivity disorder (ADHD, diagnosed when she was 14 or 15 years old), ongoing anxiety (Diagnosed when she was 16 years old), depression. Concomitant medication included ongoing methylphenidate (has been taking for about 4 or 5 years) for ADHD, to help focus and keeps her sane, ongoing primidone (has been taking less than a year) for hand tremors, ongoing fluvoxamine maleate (taking for about 4 years) for anxiety depression. The patient previously took first dose BNT162B2 on 21Dec2020 around noon, intramuscular injection in upper left arm for preventative (Lot: EJ1685). No other prior vaccinations within 4 weeks. No AE following prior vaccinations. The patient got the second dose yesterday (reported on 12Jan2021) around noon and she was experiencing not so great side effects. The biggest thing was headaches that were pretty debilitating. She was experiencing confusion and muscle aches all over. Stated that all the side effects started around the same time around 9 pm last night. The patient reported that her fever was down a bit so she was a little bit more coherent. Fever was slightly improved at 101.5. The patient took a few medicines for ADHD or anxiety and was wondering if they could have interacted with the vaccine. The events did not require a visit to emergency room and physician office. The patient reported her headache with medication was slightly better, but consistently the same. Treatment for headache inclued Ibuprofen. Outcome of event headache and fever was recovering, of event muscle aches all over was not recovered, of event confusion was unknown.

09:22: complained of throat and roof of mouth feel warm and itchy A: no difficulty talking, swallowing, breathing; clear speech, concise sentences 09:33 Per patient, her "throat feels better, it's almost gone". She left with her mom. Patient instructed to seek medical attention if any breathing difficulties.

Headache; fatigue; body aches; This is a spontaneous report from a non-contactable healthcare professional (patient herself). A 19-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration in the left arm on 13Jan2021 15:30 at single dose for COVID-19 immunisation. Medical history and concomitant medications were none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. On 14Jan2021 06:00, the patient experienced headache, fatigue, and body aches. No therapeutic measure was taken as a result of the events. Clinical outcome of events was recovering. No follow-up attempts are possible, information about lot/batch cannot be obtained.

Shortly after the vaccination I developed a headache with changed to severe migrane with extreme sensitivity to light and sound. Went to the urgent care and was given Ketrolac and Compazine. The headache lasted about 48 hrs in migrane status and lessened and finally resolved within 3 or 4 days.

While in monitoring area, patient stated she got nauseated, lightheaded, dizzy, sweaty, and was getting tunnel vision. This was at 16:07. She was wheelchaired to monitoring area, VS taken: BP 100/60, HR 76 BPM. Pt returned to baseline, she felt better with rest, gatorade, and water PO. Wheeled to vehicle, mother driving home stable.

About 8 hours after vaccine, sore arm began and has continued to the present time this next morning. About 20 hours after vaccine, this morning, woke up with a fever, chills, nausea, and dizziness. All of these symptoms I am still currently experiencing about 23 hours after the vaccine.

Patient began feeling sweaty, shaky, and nauseated. Eventually started ?seeing stars.? BP 40 min after vaccine was 90/50 pulse 110. Patient advised to drink water. 1 he 10 min after BP 140/80 pulse 80 stated she was feeling a little better but wanted to go home with roommate. Advised if symptoms are still present would prefer she stay on site but she declined. Counseled on signs and symptoms which would warrant further follow up. At no point did the patient complain of difficulty breathing, sore throat, mouth or facial swelling, or itching.

About 5 minutes after receiving vaccine, patient reported flushing, severe shortness of breath, and chills. Onset and worsening of symptoms was very quick and decision to administer 0.3mg epinephrine and call 911 was made. Patient airway was monitored until EMT arrived and patient taken to hospital for monitoring. Patient underwent further monitoring but was released after a few hours arriving at hospital.

Anaphylactic reaction; Throat was swollen shut, couldn't talk or breathe; Throat was swollen shut, couldn't talk or breathe; Throat was swollen shut, couldn't talk or breathe; loss of consciousness; brain fog; headache; fever; severe body aches and joint aches that make movement difficult; severe body aches and joint aches that make movement difficult; severe body aches and joint aches that make movement difficult; persistent chest pain/pressure; low blood pressure; some swollen and tender bilateral lymph nodes in my neck/trapezius/left (injection site) axillary region; fatigue; decreased appetite due to nausea; decreased appetite due to nausea; This is a spontaneous report from a contactable healthcare professional. A 19-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the left arm on 25Jan2021 08:45 at a single dose for COVID-19 immunization at a hospital. Medical history included type 1 diabetes mellitus, Celiac disease, COVID-19, and heartburn. Concomitant medication included insulin lispro (HUMALOG), spironolactone, fluvoxamine, and alprazolam (XANAX XR). The patient previously took gluten, magnesium ,and iodine and experienced allergies. On 25Jan2021 09:00, patient had an anaphylactic reaction. Throat was swollen shut, couldn't talk or breathe, loss of consciousness, brain fog, headache, fever, severe body aches and joint aches that make movement difficult, persistent chest pain/pressure, low blood pressure, and some swollen and tender bilateral lymph nodes in my neck/trapezius/left (injection site) axillary region, fatigue, and decreased appetite due to nausea. Patient had a doctor or healthcare professional visit, went to emergency room/department or urgent care, and was considered life threatening illness (immediate risk of death from the event). Events was treated with epinephrine, diphenhydramine (BENADRYL), paracetamol (TYLENOL) and had oxygen. Patient was not tested post vaccination. The patient is not pregnant. The patient has not recovered from the events.; Sender's Comments: There is a plausible time relationship between vaccine administration and onset of the events in a subject with allergic diathesis. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Chills; Body/muscle aches; Body/muscle aches; hot flashes; fatigue; malaise; nasal drainage; arm soreness in injection arm; This is a spontaneous report from a contactable other healthcare professional (patient). A 19-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on the left arm on 16Jan2021 11:00 at a single dose for COVID-19 immunization. Medical history included Acid Reflux. Concomitant medication included valacyclovir [valaciclovir] (VALACYCLOVIR [VALACICLOVIR]) and famotidine. On 16Jan2021 19:00, the patient experienced chills, body/muscle aches, hot flashes, fatigue, malaise, nasal drainage and arm soreness in injection arm. No treatment was received for the events. The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. No known allergies. Patient was not pregnant. Outcome of the events was recovered on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

non stop vomiting; headache; eyes hurt; cloudy feeling in my head; done nothing but Sleep; This is a spontaneous report from a contactable consumer (reporting for herself). A non-pregnant 19-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 15Jan2021 12:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) for COVID-19 immunizatio. The patient experienced non-stop vomiting, headache, eyes hurt, cloudy feeling in my head and done nothing but sleep on 15Jan2021 14:00. There was no treatment received for the events. The outcome of the events was not recovered. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.

rashes on arm getting worse and had one on chest and then on legs; I felt like I was gonna pass out and I did it right when I got to my house; I felt like I was gonna pass out and I did it right when I got to my house; She was lightheaded and extremely dizzy; huge headache; arm didn't hurt when she got the shot but 30 minutes later it hurt so bad; throat hurt extremely bad; This is a spontaneous report from a contactable health professional, the patient. A 19-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the left arm on 11Jan2021 at 15:00 (at the age of 19-years-old) as a single dose for COVID-19 immunization. Medical history included allergies to latex, oranges, and adhesive. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate (ADDERALL), hydroxyzine and celecoxib (CELEXA). The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Her arm didn't hurt when she got the shot but 30 minutes later, on 11Jan2021 at 15:30, it hurt so bad. On 18Jan2021 at 15:00 (also reported as the Monday of the vaccination), the patient experienced a feeling like she was going to pass out, at cheer practice, and did it right when she got to her house. She was lightheaded and extremely dizzy the whole time at practice and had a huge headache. Also, when she got to practice at on 18Jan2021 at 15:15, she noticed the rashes on her arm getting worse, and on her chest and then on her legs. Then, on an unknown date in Jan2021, her throat hurt extremely bad, so she gargled with salt water and it felt a little better. The patient was not treated for the events "I felt like I was gonna pass out and I did it right when I got to my house", "She was lightheaded and extremely dizzy", "huge headache", "rashes on arm getting worse and had one on chest and then on legs" and "arm didn't hurt when she got the shot but 30 minutes later it hurt so bad"; and was treated for "throat hurt extremely bad" as the patient gargled with salt water. Since the vaccination, the patient had been tested for COVID-19 via rapid nasal swab on 18Jan2021 with a negative result. The clinical outcome of "I felt like I was gonna pass out and I did it right when I got to my house" and "arm didn't hurt when she got the shot but 30 minutes later it hurt so bad" was unknown; of "She was lightheaded and extremely dizzy", "huge headache", "rashes on arm getting worse and had one on chest and then on legs", "throat hurt extremely bad" was resolving. Information on the lot/batch number has been requested.; Sender's Comments: Considering the temporal association, a causal association between administration of BNT162B2 and the onset of pass out cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. 40.~

Flu symptoms- 3 days and continuing, began about 5 hours post-2nd vaccine dose: 101-102 degree fever, chills/sweating, severe headache, stiffness in head/neck/shoulders/back, dizziness, extreme fatigue, nausea

Soreness at injection site began shortly after injection Fever began at approximately 8:00 pm the day of the injection (2/7/2021) self treated with Acetaminophen tablets Headache upon waking up the next morning (2/8/2021) self treated with Acetaminophen tablets

Fever; Nausea; Headache; Chills; Ache; she wasn't feeling well; This is a spontaneous report from a contactable consumer (patient's mother). A 19-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Batch/lot # EL8982) at single dose at right arm on 24Jan2021 15:00 for Covid-19 immunisation, administered at school/student health clinic. The patient medical history was none. There were no concomitant medications. The patient received the 1st dose of bnt162b2 (BNT162B2, Lot Number: EL1284 and Expiration Date: Apr2021) Intramuscular at single dose in her left arm on 03Jan2021 at around 4:00 PM for Covid-19 immunisation. No additional vaccines administered on same date of BNT162B2. No prior vaccinations (within 4 weeks). On 25Jan2021 the patient experienced fever, nausea, headache, chills, ache, she wasn't feeling well. The patient woke up on 25Jan2021 morning, and was kind of achy. The patient underwent lab tests and procedures which included body temperature: 99.8 on 24Jan2021. Reporter checked her daughter's temperature around on 25Jan2021 an hour before this report, and her daughter has a fever of 99.8, clarifying her daughter's temperature is running about 2 degrees higher than normal. Fever was treated drinking water, and patient uncovered herself to cool her body, and was using cold compresses. The patient was able to eat something, even though, she has some nausea and headache. The patient was feeling well enough to participate in remote learning from home, and she was resting her head on a pillow. The patient had chills on 25Jan2021 morning while in bed. The patient was a healthy, active, who exercises regularly, but and did not go to the gym on 25Jan2021morning because she was not feeling well. No event required a visit to Emergency Room or physician office. No relevant tests performed. The outcome of she wasn't feeling well was unknown, of all other events was not recovered.

low-grade fever; headache; nausea; This is a spontaneous report from a contactable consumer. A 19-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 24Jan2021 at single dose for covid-19 immunisation. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for covid-19 immunisation. Yesterday (24Jan2021), the patient experienced a low-grade fever, headache, and nausea. Outcome of the events was unknown. Information about lot/batch number has been requested.

off breathing patterns; Headache; Chills/shivering; body aches; extreme thirst; weak; high temperature; This is a spontaneous report from a contactable healthcare professional (patient). A 19-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ez3249), intramuscular at the left arm on 25Jan2021 15:00 at single dose for COVID-19 immunization. Medical history included Type 1 diabetes and hypothyroidism. Concomitant medication included insulin. The patient previously took the first dose of BNT162B2 on 04Jan2021 intramuscular on the left arm for COVID-19 immunization. The patient experienced off breathing patterns, headache, chills/shivering, body aches, extreme thirst, weak, and high temperature on 26Jan2021 12:00. The patient did not receive any treatment for the events. The outcome of the events was recovered with sequel.

atient received 2nd dose of Pfizer Covid19 vaccine today at approximately 9:35 AM. Patient received 1st dose on 1/15/21. Patient has history of anyphylaxis and was instructed to wait and be monitored for 30 minutes after vaccine. Patient alerted nurse responsible for monitoring that she was experiencing an itchy throat and difficulty swallowing. Nurse alerted nursing supervisor, and nursing supervisor brought patient into a clinic room immmediately. BP 178/110 O2 97% room air. Epi 0.5mg 0.5ml administered LD IM at 10:01 AM. Benadryl 100mg 2ml administered RD IM at 10:01 AM. EMS called. Patient reported some improvement of symptoms approximately 1 minute after EPI/Benadryl injections. EMS arrived at 10:10 AM and transported patient to hospital. Attempted to call patient on 2-10-21 and left message. No response.

At 10:45 pm about 6-7 hours after receiving the vaccination at 2:10 pm I developed symptoms of tiredness, chills, and fever. I then slept roughly 9.5 hours. The symptoms continued until morning when I took some ibuprofen to help lower the fever. At 10:30 am I had a fever of 100.1 and at 12:45 pm I currently have a fever of 99.3. I feel as if I am gradually getting better.

Bell's Palsy; low grade fever; body aches; chills; This is a spontaneous report received from a contactable healthcare professional (patient) communicated to a Pfizer colleague. A 19-year-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/lot number: EL9261 and expiry date: 31May2021) via an unspecified route of administration to Left Deltoid on 27Jan2021 09:30 at single dose for COVID-19 immunization in workplace clinic. Patient medical history included factor V Leiden mutation (Blood Clotting disorder), common migraines, pelvic pain diagnosed 5 years ago, on 05Nov2020 hip surgery on the right side, foot surgery on 21Jan2021 with local anesthesia and nerve block in the left foot. Patient family history included mother has same Factor V Leiden mutation and father has iodine and shellfish allergy. Concomitant medications included cetirizine hydrochloride (ALERCET), gabapentin, prazosin and colecalciferol (VITAMIN D), all from an unknown date and ongoing. The patient had not received other vaccinations within 4 weeks. Patient past drugs included chlorhexidine which she experienced allergy: super itchy skin burning and lidocaine injection for local anesthesia. Patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1284) in the right deltoid on 06Jan2021 at 09:35 Am for COVID-19 immunization. Second dose on Wednesday on left side and she stated that she had mild side effects low grade fever, body aches and chills on 27Jan2021 evening. No treatment was given for low grade fever, body aches and chills. She reported that she began to feel left sided swelling, tingling, and drooping of her face on the evening of 29Jan2021. She further described that on Friday (29Jan2021) evening her face was super weak, 1st manifestations were the eye and the left side of her face droopy and neck pain. She took 2 BENADRYL at 8:00 pm and went to sleep. At 08:00 AM next morning she took TYLENOL as her jaw and neck were hurting. She mentioned that while driving to work it got aggravated. She called advice line and she was instructed to go to emergency room. She went to emergency room and was diagnosed with Bell's Palsy on 30Jan2021 via physical exam. She has been prescribed steroids and antiviral for now (30Jan2021). Started Saturday (30Jan2021) on 20 mg prednisone daily PO (orally) for 5 days. VALTREX 1 tab PO (orally) 3xday. Erythromycin 0.5% unguent for eye 4X a day for a week. Her primary doctor increased 60 mg daily prednisone and VALTREX for a total of 10 days. And prescribed lubricant eye drops. Outcome of events Bell's Palsy was not recovered while for other events was recovered on an unspecified date in Jan2021. No follow-up attempts are possible. No further information was provided.; Sender's Comments: Based on a compatible temporal relationship, causality between event Bell's palsy and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Fever over 100 degrees; swollen lymph nodes; unable to swallow; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 19-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiry date unknown), via an unspecified route of administration in the left arm, on 30Jan2021 07:30, at single dose, for COVID-19 immunization, at the hospital. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Concomitant medication included an unspecified birth control medication. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 vaccine. The patient experienced "fever over 100 degrees and swollen lymph nodes causing me to be unable to swallow" on 30Jan2021 at 22:00. No treatment was received for the events. The outcome of the events was not resolved. The reporter assessed the events as non-serious.

Patient states she feels nauseous after receiving vaccine and developed a headache. b/p 144/76,p-83, R 18, 02 sat 99% Temp 96.1. After observing patient for 20 minutes patient c/o sever left sided abd pain and was taken to ED for further evaluation

Bells Pals half of face, numbness, weakness, headache, fever, diarrhea, nausea, chills, body aches, fatigue., tics and then a few days later had a gran mal seizure, forgetfulness

Extreme pain to injected arm a few hours later lasting for about an hour, arm sore to the touch for two days, feverish feeling and body aches 12 hours later.

Awoke the next morning with severe headache, fatigue, muscle pain (?felt Like being hit by a truck?). Slept 1.5 days, out of breath walking to bathroom from bed. Treated with sleep and sips of water, soup. However, her mild daily migraine became more severe 2 weeks after the 2nd dose, her vision has worsened, and her eyes spontaneously dilated with pounding headache a few days ago along with nausea. It appears this 2nd dose has made her daily (mild) migraines much more severe.

1530: Approximately 10 minutes after receiving vaccine patient reported having itching to throat, and hands. Patient stated she did have a Depo-Provera Injection after 1st vaccine approximately 3 weeks ago. Pt did state she pre-medicated herself with Benadryl 50mg orally at approximately 1300hrs today. Mom was present with patient while covering physicians and EMS on duty assessed patient. VS:112/82-B/P, 123-HR, 18-RR, SaO2 98% on RA. Allergies: Steroids, fish FMHx: Sports induced asthma and gallstones. 1550: Patient had notable facial swelling eye redness and flushing. 0.15 Epinephrine IM via home Epi-Pen self delivered by patient's mother for increase SOB, and tightness in chest. EMS transport called to transport patient to location. VS:118/86-B/P, 100-HR, 18-RR, Sa02 96% on RA. 1600:Transfer of care to EMS staff assisting in transfer of the patient.

Headache, joint pain, light fever, light-headedness. I almost passed out trying to walk to the dining hall for dinner.

Client complained of pressure in her head & down her face 5 minutes after receiving the vaccine. Client provided water & crackers, admitted to not eating enough before arriving to clinic. There was no improvement of S/S P 1 hour, offered ambulance, refused. Discharged home to with father Client/Dad informed to provide Tylenol/Food/fluids & Rest If no improvement c s/s to take her to the Emergency Room. Family enrolled on site c v-safe & informed to report s/s. Pt was up & ambulatory upon discharging.

One hour after vaccination, she experienced itchy throat, facial flushing, tongue swelling, respiratory distress, and abdominal pain and cramping. Patient self-administered epinephrine injection 0.3 mg in the car on the way home. Administered a second dose at home 45 minutes later. Then went to Hospital ER. she was given injections of benadryl and phenergan. observed and released.

Patient had received the pfizer covid vaccine, and approximately 10 minutes after dose, she felt light headed, headache, and nauseous. 12.5mg benadryl was given in the idea that she had an allergic reaction. over the next few minutes she had begun to talk about itchy, hot throat and immediately administered epinephrine and called 911. paramedics showed up briefly after, informed about her heart condition, afterwards paramedics took her out and under her care at this time. Epi administered into left

Got second dose of vaccine the morning of March 10th. Had the "expected" symptoms of fatigue, headache, and chills the evening of March 10th. Woke up on March 11th around 6:50am and felt the same symptoms as the night before but also really hot and nauseous, stood up and began to slowly lose vision. Went to parents for help and they saw me pass out and collapse. Went to Emergency Room and they found I had a really high heart rate and I received an IV to help with rehydration. Was released after that and have continued to have the same symptoms plus muscle soreness but no longer feel as dizzy and haven't had any issues with vision or consciousness since.

Swelling of the face and eyes, high fever, loss of appetite, rapid heart rate. The swelling of the eyes has lasted 5 days now but the face swelling went away after 3 days. I still have a high fever on and off and the rapid heart rate went away a few hours after injections

Felt fine the night before. Woke up at 6:00 a.m. with fever, chills, puffy bottom eye lid, watering, irritated eyes, redness and swelling on upper cheeks, swollen at site of vaccination, slight redness at vaccination site, headache, and my body felt heavy and slow. Towards the Evening, I still had symptoms such as redness in eyes, slightly swollen bottom eyelids, redness and swelling in upper cheeks, fever, chills, watering, irritated eyes, headaches, and my body feels slow, but not as slow as in the morning.

Within 12 hours after the injection I was feeling a little dizzy and very warm. I went home and checked my temperature before getting into bed and saw it was 103. I had chills, pain in my arm, very hot to the touch, and could not sleep through the night with the amount of pain and discomfort I was in.

3/17/21-3/18/21: Nausea, vomiting, high fever (103F), diarrhea, muscle soreness & weakness, shakes, dehydration, migraine 3/19/21-3/21/21: chest tightness, muscle pain and weakness, low grade fever (100-101F), sore throat

Immediate reaction of nausea and question of mild throat soreness. No SOB/wheezing/hives/hypotension. Resolved within 30 min without intervention.

Temporary loss of taste started on 3/21 that lasted 12 hours. Fatigue and chest tightness from 3/20-3/23. Occasional nausea

at 1pm EST on 3/19/21 patient reports onset of fatigue. then around 3pm 3/19/21 she developed nasal congestion, sore throat, increased fatigue, muscle aching generalized, backache generalized mid and lower back, chills, headaches, loss of appetite, swollen neck glands. She visited the Health Clinic on 3/20/21 at 3:40pm at which time she was noted to have temp of 100.6 and heart rate of 108. General exam indicated some tender anterior nodes, nasal mucous, and fatigued appearance.

Numbness / tingling / parasthesia in legs from toes through pelvis started about 24 hours post vaccination. Still continuing. Also experienced transient fever, headache, sore throat.

Client states she developed severe headache and weakness about an hour after receiving vaccine. The following morning she awoke with nausea, vomiting, sore throat. She reports feeling better today, though not completely well. Client states she called and reported to CDC.

The next morning after I got the second dose of the vaccine, I felt incredibly ill. Stomach was aching to the point I thought I was going to throw up, my joints were aching to the point it hurt to move, my skin hurt so touch, and I had a slight quick fever. These symptoms lasted all day, but went away the day after (Wednesday 24, 2021).

3/28/2021 Pt. was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening . During the observation period, she experienced an adverse reaction with the following symptoms: dizziness, FLUSHED, WARM AND SWEETY, NAUSEA WITH DRY HEAVES Assessment : Time of assessment 0841. Alert and oriented. Actions taken: VS taken at 0851- bp-131/92, p- 90, o2- 100%, VS RECHECKED - BP-112/78, P- 66, O2- 100%, 0855 SYMPTOMS RESOLVED, 0901 BP- 99/68, P- 67, O2-100% DISCHARGED HOME WITH FAMILY MEMBER. Medications administered: Famotidine (Pepcid) 10 mg by mouth. Time: 0851. Administered by RN. BENADRYL 25 MG po X 1 Disposition: Reports no further symptoms of adverse reaction after observation for 45 minutes. Discharged home. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 3/28/2021 8:36 AM 0.3 mL 12/11/2020 Intramuscular Manufacturer: Pfizer, Inc Lot: ER8730 NDC: 59267-1000-1 Electronically signed by RN at 3/28/2021 11:13 AM Immunization on 3/28/2021 Detailed Report Note shared with patient

Patient woke up at 1ma the morning after her second dose of the Pfizer Bio N Tech vaccine. She was having "convulsions" of arms and legs but remained fully conscious. this lasted 30 min. she was able to speak during this time. It stopped. She returned to sleep. no loss of bowel or bladder control. She went back to sleep once it stopped. she woke up later in the AM. she had mild headache. she called Health Clinic and advised what happened earlier. she was advised to go to ER for evaluation. She did She has made full Recovery.

Shaking, chills, fever, severe muscle ache, headache, very painful swollen lymph node in armpit, nausea, apetite loss

4:50PM PT BECAME LIGHT HEADED - N/V, DIAPHORETIC. PLACED IN WHEEL CHAIR AND MOVED TO COT. 'FEELING A LITTLE BETTER'. A/O, RESP WITH EASE. NO PAIN, NO SOB. 5PM NOW PINK, W/D. 5:15PM FRIENDS HERE TO DRIVE PT HOME. AMBULATORY TO EXIT - GAIT BRISK AND STEADY. 4-2-21 10:30AM TC: PT STATES SHE FEELS 'FINE NOW'.

Sore throat 2 days after vaccine for 2 days, headache after vaccine for 2 days for 1 day, chest pain for a few hours 4 days after vaccine, joint pain for 4 days, body aches for 5 days, blue feet and grey nails for 30 seconds 3 days after vaccine, couldn't walk for 5 days after vaccine, a lot of weakness everyday for 5 days, bruises on both feet 4 days after vaccine for 3 days.

Systemic: Abdominal Pain-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Severe, Systemic: Visual Changes/Disturbances-Severe, Systemic: Vomiting-Severe

Patient was receiving her first dose of the Pfizer COVID-19 vaccination and several minutes afterwards she developed dyspnea, intractable cough, nausea, sensation of her throat closing, difficulty breathing and sensation of facial swelling. In the ED, the patient was administered epinephrine 0.3 mg IM and was given albuterol inhaler, Zofran 4 mg IV, Solu-Medrol 125 mg IV, 1 L fluid bolus and milligram Pepcid IV and 50 mg of Benadryl IV. Pt received discharge instructions and stated understanding concerning medications, follow up care and when to seek emergent care. Pt PIV removed. Pt verbally acknowledged discharge instead of signing paperwork. Pt was ambulatory to discharge with all belongings and was escorted to the front of the bldg by staff.

Soreness at injection site which makes it painful to move arm and sleep on arm, headache, tiredness, overall feeling unwell

Pt walking to Observation: RN reports "deer in headlights look" pt reports feeling dizzy, SOB, fatigue & weakness. Pt brought to Triage in . transferred to gurney, EMTs and MD at beside. pt very tired. BF gives hx of pt responding like this before. (nothing to do with vaccine. No adverse effect with dose 1.) Pt states she was born without inferior vena cava and has CA Stents. States she "does this and then gets transferred to or my Cardiologists office." Can't recall last episode. 14:30 EKG NSR, Pt weak BUE & BLE, cant move legs. Pt states she has not eaten today but had 3 shots of Expresso. 14:31 IV started in R-hand, 200ml NS bolus. BS 107 mg/dL. 14:58: Decision to transfer patient to ER as not improving on weakness. Transferred to Hospital via AMB @ 15:01.

Harsh Body aches and chills...hand shook to the point where I couldn?t hold a pencil. High 102 fever. Dizziness

Patient reported headache and lightheadedness within 15 minutes of vaccination. Patient did not improve and was transported to ER by EMS.

When I first got the vaccine, i got dizzy and sick to my stomach with a headache. I decided to leave after sitting for 20 minutes and go back to work because it got a little better. on tuesday. A few hours later, my chest started to ache and my throat started to hurt. thinking I had asthma due to the heat, i ignored it and used my inhaler. By the next day, I was coughing and it hurt worse. I was still dizzy but worse, felt neasious and had a headache. I used my inhaler twice with no help. My arm started to hurt to move, and my injection spot became a red lump. By Thursday, I could barely take a normal breath. It hurt to walk, talk, yawn, sneeze or anything that lifted my need to breathe above bare minimum. It hurt greatly and I couldn't take a full breath. I felt like my lungs were swollen and my throat hurt to swallow. I was very dizzy and had horrible nausea.

Feeling a bit more sleepier than normal, there is some slight soreness around the site of injection, nothing severe yet

Upon resting later the day of my vaccine at home, my left arm because extremely painful and sore. Which I found to be normal and expected. However, I became very exhausted suddenly and ended up falling asleep 2-3 hours before my normal bedtime. I woke up 12 hours later unable to motivate myself to get out of bed. Finally, I did and went to go take a shower. I had chills as soon as I got out of bed and had to sit down in the shower for 10 minutes out of exhaustion and had the water running extremely hot but I was still cold. My arm was still in extreme pain. Finally, I arose from the shower floor and began showering when I started to feel as if I was going to puke right away. I laid down in the shower quickly becoming dizzy, and tried to puke. I dry heaved once to no avail. Immediately after dry heaving, my ears went numb and the shower noise was barely audible. My hands went completely numb. Home alone, I knew I needed to get out of the shower before I passed out. I managed to step out of the shower before immediately falling and possibly blacking out for some seconds and fell to the floor and laid there for a minute. Finally, I was somehow able to grab a towel and struggle to my bedroom and laid there numb for about 10 minutes. This episode ended at about noon but for the rest of the day, I had to sleep on and off, it exhausted me to try and eat, I had hot flashes, more dizziness, arm pain, and nausea. I called the doctor and they said there was nothing they could do and my symptoms were normal since I had COVID-19 in December.

Experienced the following after 7 minutes of the vaccine: shortness of breath, lightheadedness, dizziness, chills, and fast heart beat. Symptoms began to subside after 5 minutes and nausea and chest pain began After another five minutes, another episode of shortness of breath, lightheadedness, dizziness, chills, and fast heart beat Symptoms slightly bettered and was taken to emergency room Fast heart rate still continues, along with lightheadedness, shortness of breath, and occasional dizziness

8:00pm-arm started to be sore 4:00am-chills and warm head 12:00pm-extremely tiredness when chills and a warm head 9:00am-feeling like i need to puke/extremely low energy

I had a continuous headache from about 9 pm the day of my vaccine all the way through to about 12 pm the next day. It never went away even while I was sleeping. I know this because I woke up multiple times throughout the night because of it. Tylenol, an ice pack, and peppermint oil did not help it. I get migraines often and these always work for those but didn't work for the headache caused by the vaccine.

Patient began feeling dizzy immediately after administration. She said she could not open her eyes/ see. She became extremely sweating and pale. She never lost consciousness but could not regain her strength/ color.

The night I got the vaccine I was studying and all of a sudden I couldn?t finish my sentence and felt like I was going to pass out. My eyes unfocused, I got slightly nauseous, I went absent, and my heart raced. I couldn?t focus the rest of the night I felt very off and strange. It was very sudden and scary. I shook for like 30 minutes after. It has been happening on and off in very short durations for four days now.

Worsening over 6 days: arm injection swelling and sharp pain (severe, 1st day on: ice pack), headache (severe: advil, tylenol, thera flu), muslce aches all over the body (medium: 2nd day on); tiredness (medium-severe: 1st day on), sore throat (severe: 3rd - 5th day: cough drops); congestion/nasal and chest with cough and yellow mucous and sneezing (severe: 4th day on: nyquil); difficulty breathing (medium: 5th day on); runny nose (medium: 4th day on); temperature (5th day on, highest of 102: tylenol); nausea/vomitting/diarrhea (5th day only: bland food, BRAT diet), swollen lymph nodes (medium: 4th day on). Possible loss of smell and taste but could be due to congestion. Doctor prescribed (and was carried out): antibiotic (Cefdinir, just in case) and steroid shot.

Patient reported light headedness, shortness of breath, and itchy throat about 15 min after vaccine. Patient took 50 mg diphenhydramine PO, remained on site for about an hour, reported improvement in symptoms at that time and left.

The day after I received the 2nd dose I developed a strange and extremely painful type of headache. Ever since then I have that same type of headache about once a week. No over-the-counter meds, heat or ice, sleep, etc. will help subdue it. The worst of it lasts a whole day. The head then lightly lingers for 1-2 days after. This headache impedes on my ability to work and go about daily activities.

Patient was walking to observation room when she began to feel dizziness, vision changes and tinnitis resulting in syncope 1-2 minutes. Patient was on floor in sitting position supported by staff member. Diaphoretic. Pale. Unresponsive <1 minute. No head or face injury noted. No bleeding, swelling or ecchymosis noted. Full ROM to neck, LE and UE. Denies pain, CP, SOB, HA, palpitation or vision changes. BP 94/53 HR 99 O2 99% Patient was assisted to chair. A&O x 4. Reports that she was fasting x 1 month, reports eating small amount of granola bar and small amount of water. Patient was observed for 30 minutes. d/c home in stable condition w/ dad. ED warning s/s discussed. Patient and father repeated instructions w/ good understanding.

Patient began to feel sick and dizzy about 15 minutes after vaccine was administered. She very nearly collapsed but pharmacy staff quickly laid her down with feet up and she was given water and a sucker. She soon began to feel better. After a few minutes she was able to sit up and was fully recovered after 30 minutes

Upon discharge c/o nausea and headache. VS 118/76, OxSat 97%, HR 96. Verbalizes lightheaded dizziness. Appropriate to questions, sat additional 15 min. Symptoms relieved, medics monitored and ok to d/c home

2:00 am I woke up with diarrhea and vomiting. I vomited again at 4:00 am. I vomited again at 5:00 am. I had diarrhea again at 8:00 am. I was not able to eat anything all day. Very ache and weak all day. Slight headache. Slept most of the day. Hardly able to stand in shower. Woke up the next day (4/17/2021) feeling only a slight headache.

Face felt numb at 12pm Lips started feeling weird which they turned out to be swollen 12:37 Mouth started twitching into a smile 12:45pm Face started swelling 1pm Face started becoming red 1:50pm Went to doctor at 1:54pm Low grade fever at 2:10pm Hives started forming on eyes 2:30pm Face still twitching and mouth still stuck unable to open mouth 2:35pm Zertec provided by doctor and swelling went down and was able to open mouth but the involuntary twitch still occurring 2:40pm Mouth has involuntary twitching since April 16 and currently the same as yesterday it?s April 17th

I Received the shot at 10:45am on April the 15th, no side effects except arm soreness afterward. Then at around 7:40pm that same night, I began getting terrible itchy on my face, back, arms, and neck. It worsened and I started having trouble breathing (it felt like my throat had tightened)/a hoarse voice, and my pulse was faster than usual and I felt woozy and tired.. I called a nurse hotline and she recommended for me to be seen at an ER, and I went home to tell my parents and they called a doctor friend, and I was told to take Benadryl and if anything got worse to go to the ER. The next day when I woke up I felt mainly tired and had a slight cough and was scheduled a telehealth appointment, and I am taking Zyrtec 10mg and Pepsin 20mg daily x one week with Benadryl as a back up in case the symptoms flare up, and am advised to go to the ER if the breathing issues return. In terms of symptoms now, I am just a little itchy.

Night of vaccination: sweats, fever, headache, stomach ache, injection site pain Day after vaccination: sweats, fever, headache, injection site pain swelling and tenderness, nausea, diarrhea, muscle pain, chills, fatigue

Patient slumped into chair in the observation area. I rushed to her. She was hyperventilating, but not wheezing or making any high pitched sound while breathing. Patient was conscious, and could answer my questions coherently. Patient was told to take off her mask so she can breath more easily. Patient kept saying "I'm sorry" and was told there's nothing to feel sorry for, and we wanted to make sure she was fine. Pulse was slightly elevated. Hands were warm and sweaty. Patient asked for a bottle of water. After drinking some water she felt better. It was likely a panic attack episode. I checked on her five minutes later. She just finished talking on the phone with a family or friend. She was a lot better at this point. She agreed that that was likely a panic attack. I advised her she should be able to receive the 2nd dose later, but should consult her PCP.

SECOND DOSE ADMINISTERED ON DAY 14 RATHER THAN THE RECOMMENDED DAY 21. PATIENT WAS TIRED AND HAD CHILLS.

Fever that lasted through the night, woke up around noon after going to sleep at midnight and it was gone - I did not take medication for the fever. Body aches and chills before I went to sleep, headache like a hangover, stuffy nose.

Insomnia, malaise, soreness of entire body, nausea, vomiting (over the course of two hours), dizziness, fever, and chills

After my second dose of the Pfizer vaccine I experienced severe headache, fatigue, disorientation, and a runny nose. My symptoms lasted one week.

Patient experienced sweating weakness after injection. 10:50 B/P 89/50 Pulse 71 10:55 B/P 100.76 Pulse 76 O2 level 9811:05 B/p 105/72 Pulse 80; Patient discharged; 11:10 feeling fine with her boyfriend